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    HP:0100753: Schizophrenia

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (9)


    Name (Synonyms) Correlation
    drug3539 RO6889450 Wiki 0.53
    drug4765 Xanomeline and Trospium Chloride Capsules Wiki 0.53
    drug1561 Exercise Intervention Wiki 0.38
    Name (Synonyms) Correlation
    drug3710 Risperidone Wiki 0.38
    drug498 BI 425809 Wiki 0.38
    drug3018 PACE-Life Wiki 0.38
    drug3958 Sham Stimulation Wiki 0.38
    drug4263 TDCS Wiki 0.38
    drug3195 Placebo Wiki 0.06

    Correlated MeSH Terms (5)


    Name (Synonyms) Correlation
    D012559 Schizophrenia NIH 1.00
    D011618 Psychotic Disorders NIH 0.40
    D019967 Schizophrenia Spectrum and Other Psychotic Disorders NIH 0.38
    Name (Synonyms) Correlation
    D001523 Mental Disorders NIH 0.07
    D004194 Disease NIH 0.06

    Correlated HPO Terms (1)


    Name (Synonyms) Correlation
    HP:0000709 Psychosis HPO 0.40

    Clinical Trials

    Navigate: Correlations   HPO

    There are 7 clinical trials


    1 Restoration of Cognitive Function With TDCS and Training in Schizophrenia

    Development of interventions that can effectively target and remediate the cognitive and functional impairment associated with schizophrenia is a treatment priority. Transcranial direct current stimulation (tDCS) is a safe, non-invasive neuromodulation technique that is capable of stimulating brain activity to facilitate learning. The primary objective of this study is to evaluate the pairing of two therapeutic techniques, cognitive remediation and tDCS, as a cognitively enhancing intervention. This study is designed to address four questions. Is cognitive remediation paired with tDCS more efficacious than cognitive remediation delivered with sham stimulation? Is it possible to predict responsiveness to the intervention? Is intervention-induced cognitive change sustainable? Are there barriers to implementing this intervention in clinical practice? To examine the incremental benefit of pairing tDCS with cognitive remediation, a 110 clinically stable outpatients between the ages of 18-60 who have a diagnosis of schizophrenia or schizoaffective disorder will be enrolled in a double-blind, double-baseline, sham-controlled clinical trial. Participants will be randomized in a 1:1 ratio to receive either tDCS or sham stimulation concurrent with working memory focused cognitive remediation. Training will be offered to participants in a small group format. Training will consist of 48 sessions, with 2-3 sessions scheduled in a week. Each training session will last 2 hours. One hour will be spent completing cognitive exercises that require working memory skills on a computer. TDCS or sham stimulation will be offered concurrent with the first 20 minutes of training with a StarStim neuromodulator. One mA of anodal stimulation will be applied to the left dorsal lateral prefrontal cortex and the cathodal electrode will be placed in the contralateral supraorbital position. Upon completion of working memory training, participants will transition to a 30-minute discussion group. The discussion will focus on application of cognitive skills in everyday life. Effective strategies for approaching cognitive tasks will be described and practiced. Participant experience with aspects of the training will be monitored with self-report measures of motivation, mood, and physical reactions. To assess intervention-induced change, working memory, other aspects of cognition, functional capacity, and community functioning will be assessed pre- and post-intervention. Cognitive outcomes will be assessed with training tasks as well as tasks that are unfamiliar to participants. A performance-based measure will be used to assess functional capacity for everyday living skills and a self-report instrument will be used to assess community functioning. Potential confounds such as symptom severity, medication changes, outside treatment hours, and significant life stressors will be assessed individually every 2 weeks during the intervention phase of the study. Sustainability of intervention-induced change will be assessed with assessment sessions 6 weeks and 6 months post-intervention. Change in performance during the first 12 training sessions on two working memory training tasks, a n-back task and a complex span task, will be used to determine if early response to treatment is predictive of post-intervention outcomes. An intent-to-treat analysis will be used to analyze intervention-induced change. Regression analyses will be conducted to identify predictors of treatment response. Achieving the proposed objectives will yield important information about the efficacy, durability, and efficiency of a novel pairing of cognitively enhancing interventions. Findings will inform treatment development for patients with schizophrenia as well for patients with other cognitively compromising illnesses.

    NCT03208036
    Conditions
    1. Schizophrenia
    Interventions
    1. Device: TDCS
    2. Device: Sham Stimulation
    MeSH:Schizophrenia
    HPO:Schizophrenia

    Primary Outcomes

    Description: Working Memory Domain Age and Gender Corrected T-Scores on MATRICS Consensus Cognitive Battery

    Measure: Working Memory Capacity Composite Score

    Time: Change from Baseline Working Memory Capacity at 4 months

    Description: Average of MATRICS Consensus Cognitive Battery Attention Domain Age and Gender Corrected T-score and performance measured with d prime on the Dot Pattern Expectancy Task

    Measure: Goal Maintenance Composite Score

    Time: Change from Baseline Goal Maintenance at 4 months

    Description: Average of sensitivity measures on the Sternberg Item Recognition Paradigm and the Suppress Task

    Measure: Interference Control Composite Score

    Time: Change from Baseline Interference Control at 4 months

    Description: T-score

    Measure: The University of California San Diego Performance-Based Skills Assessment

    Time: Change from Baseline T-score on Adaptive Skills test at 4 months

    Secondary Outcomes

    Description: Total score

    Measure: First-Episode Social Functioning Scale

    Time: Change from Baseline Social Functioning at 4 months

    Description: D-prime on N-back task

    Measure: N-Back Performance

    Time: Change from Baseline N-back performance at 4 months

    Description: Total Score

    Measure: Complex Span Task

    Time: Change from Baseline Complex Span Task performance at 4 months
    2 Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of RO6889450 (Ralmitaront) in Patients With Schizophrenia or Schizoaffective Disorder and Negative Symptoms

    This study investigates the effects of RO6889450 on the negative symptoms associated with schizophrenia and schizoaffective disorder.

    NCT03669640
    Conditions
    1. Schizophrenia, Schizoaffective Disorder
    Interventions
    1. Drug: RO6889450
    2. Drug: Placebo
    MeSH:Schizophrenia Psychotic Disorders
    HPO:Psychosis Schizophrenia

    Primary Outcomes

    Measure: Change from Baseline at Week 12 in Brief Negative Symptoms Scale (BNSS) Avolition/Apathy Subscore

    Time: Baseline to Week 12

    Secondary Outcomes

    Measure: Change from Baseline in Clinical Global Impression Severity (CGI-S) Overall Scores

    Time: Baseline to week 12

    Measure: Change from Baseline in CGI-S Negative Symptoms Scores

    Time: Baseline to week 12

    Measure: Clinical Global Impression - Improvement (CGI-I) Overall Scores

    Time: Week 12

    Measure: CGI-I Negative Symptoms Scores

    Time: Week 12

    Measure: Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores

    Time: Baseline to week 12

    Measure: Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Symptom Factor Scores

    Time: Baseline to week 12

    Measure: Change from Baseline in Brief Negative Symptom Scale (BNSS) Total Scores

    Time: Baseline to week 12

    Measure: Change from Baseline in Brief Negative Symptom Scale (BNSS) Symptom Factor Scores

    Time: Baseline to week 12

    Measure: Change from Baseline in Defeatist Performance Attitude Scale (DPAS) Scores

    Time: Baseline to week 12

    Measure: Percentage of Participants with Adverse Events (AE)

    Time: Baseline through the end of the follow-up period (approximately 16 weeks)

    Measure: Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Scores

    Time: Baseline through the end of the follow-up period (approximately 16 weeks)

    Measure: Change from Baseline in Extrapyramidal Symptom Rating Scale, Abbreviated (ESRS-A)

    Time: Baseline through the end of the follow-up period (approximately 16 weeks)

    Measure: Area Under the Curve at Steady State (AUCss) of RO6889450

    Time: At pre-defined intervals from Day 7 through the end of the follow-up period (approximately 16 weeks)

    Measure: Maximum Serum Concentration (Cmax) of RO6889450

    Time: At pre-defined intervals from Day 7 through the end of the follow-up period (approximately 16 weeks)
    3 A Phase II Randomized, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of BI 425809 Once Daily With Adjunctive Computerized Cognitive Training Over 12 Week Treatment Period in Patients With Schizophrenia

    The primary objective of this Phase II exploratory trial is to provide Proof of Concept (PoC) data to assess the effect on cognition of oral once daily administration of BI 425809 given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment and adjunctive Computerized Cognitive Training (CCT).

    NCT03859973
    Conditions
    1. Schizophrenia
    Interventions
    1. Drug: BI 425809
    2. Drug: Placebo
    MeSH:Schizophrenia
    HPO:Schizophrenia

    Primary Outcomes

    Measure: Change from baseline in neurocognitive function as measured by the neurocognitive composite score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)

    Time: Up to 12 weeks

    Secondary Outcomes

    Measure: Change from baseline in cognitive function as measured by the overall MCCB composite score (including social cognition)

    Time: Up to 12 weeks

    Description: Schizophrenia Cognition Rating Scale (SCoRS)

    Measure: Change from baseline in the effect of cognitive deficit on day-to-day functioning as measured by SCoRS total score

    Time: Up to 12 weeks

    Description: Positive and Negative Syndrome Scale (PANSS)

    Measure: Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score

    Time: Up to 12 weeks

    Measure: Percentage of patients with (S)AEs

    Time: Up to 12 weeks
    4 Targeting Physical Health in Schizophrenia: Physical Activity Can Enhance Life Randomized Control Trial

    Purpose: To test the effectiveness of an exercise intervention that combines group walking, activity tracking, and heart rate monitoring (i.e. Physical Activity can Enhance Life, PACE-Life) on the physical and mental health for individuals with schizophrenia spectrum disorder. Participants: 56 individuals with schizophrenia spectrum disorders. Procedures (methods): During the baseline assessment, all participants will be provided with a Fitbit wristband and instructed how to use it. During the first group session, participants will be taught how to use their heart rate (on the Fitbit) to determine how fast participants should walk (to achieve the appropriate exercise dosage). Information on proper care, usage, and how to determine the appropriate heart from the watch, which will be used to guide the intensity of the walk will be provided to participants and reviewed at each group session. Participants randomly assigned to PACE Life clinic based group sessions will arrive at the STEP clinic to meet the entire group and leaders and be reminded of the heart rate (HR) that corresponds with the intensity of that group session. Next, the group will go outside and walk for 30 minutes. At the completion of 30 minutes, everyone will go back into the clinic for water and review of the walk. After the second group session of each week, participants will receive weekly progress reports of their steps and minutes spent walking the prior week (obtained from Fitbit devices). During this session, participants will also set individual goals for the upcoming week for both their "intensity walks" and total steps per day. Participants randomly assigned to Fitbit Alone will be given a Fitbit and shown how to use it by study staff. Participants will also be given information on current recommended physical activity guidelines (150 min/week of moderate intensity exercise) and will be told that study staff may be contacting them on a weekly basis (or shorter, if necessary) if it looks like participants are not wearing their Fitbit for a certain number of days (e.g. 3 consecutive days) or to troubleshoot any issues. If necessary, participants might be invited to come to the clinic to get assistance on any Fitibit or exercise related issues.

    NCT04173572
    Conditions
    1. Schizophrenia
    2. Schizoaffective Disorder
    3. Brief Psychotic Disorder
    4. Schizophreniform Disorders
    5. Unspecified Schizophrenia Spectrum and Other Psychotic Disorder
    Interventions
    1. Behavioral: PACE-Life
    2. Behavioral: Exercise Intervention
    MeSH:Disease Schizophrenia Psychotic Disorders Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders
    HPO:Psychosis Schizophrenia

    Primary Outcomes

    Description: The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness).

    Measure: Difference in Participant's Total Distance During 6-minute Walk

    Time: Baseline and the last study visit (Up to 20 weeks)

    Secondary Outcomes

    Description: Mean difference in overall minutes spent walking per week from baseline to last study visit (up to 20 minutes). This information will be obtained from the participant's Fitbit. Higher scores reflect more minutes walking.

    Measure: Mean Difference in Minutes Spent Walking

    Time: Baseline and the last study visit (up to 20 weeks)

    Description: Mean difference in daily steps from baseline to last study visit (up to 20 weeks). This information will be obtained from the participants Fitbit. Higher scores reflect more daily steps.

    Measure: Mean Difference in Daily Steps

    Time: Baseline and the last study visit (Up to 20 weeks)

    Description: Mean difference in overall score from baseline to last study visit (up to 20 weeks). The UCLA Loneliness scale is a 20 item scale. Answers are on a 4 point scale with options "I often feel this way," "I sometimes feel this way," "I rarely feel this way," and "I never feel this way." Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness).

    Measure: Mean Difference Overall UCLA Loneliness Scale Score

    Time: Baseline and the last study visit (Up to 20 weeks)

    Description: Mean difference in the overall score from baseline to last study visit (up to 20 weeks). The PANSS is a semi-structured interview using a 30-item scale to evaluate the presence, absence and severity of Positive, Negative and General Psychopathology symptoms of schizophrenia. All 30 items are rated on a 7-point scale (1 = absent; 7 = extreme). Possible scores range from 30 to 210. Higher scores reflect worse outcomes (i.e. greater symptoms of psychosis).

    Measure: Mean Difference Overall PANSS Score

    Time: Baseline and the last study visit (Up to 20 weeks)

    Description: Mean difference in body weight change from baseline to last study visit (up to 20 weeks). Expected normal BMI ranges from 14 to 54. Higher scores reflect worse outcomes (i.e. greater body mass).

    Measure: Mean Difference in Body Weight Change

    Time: Baseline and the last study visit (Up to 20 weeks)

    Description: Mean difference in blood pressure change from baseline to last study visit (up to 20 weeks).

    Measure: Mean difference in blood pressure change

    Time: Baseline and the last study visit (Up to 20 weeks)

    Description: Mean difference in resting heart rate change from baseline to last study visit (up to 20 weeks). Expected normal heart rate ranges from 40 to 120. Higher scores reflect worse outcomes (poorer heart condition).

    Measure: Mean Difference in Resting Heart Rate Change

    Time: Baseline and the last study visit (Up to 20 weeks)

    Other Outcomes

    Description: Mean difference in composite motivation score from baseline to last study visit (up to 20 weeks). The BREQ-2 is a 19 item self-report scale. Answers are on a 5 point Likert scale ranging from 0 to 4. 0 corresponds to "not true for me" and 4 corresponds to "very true for me." Possible scores range from 0 to 46. Higher scores reflect better outcomes (higher autonomous motivation to exercise).

    Measure: Mean Difference in Composite Motivation Score on the Behavioral Regulation Exercise Questionnaire (BREQ-2)

    Time: Baseline and the last study visit (Up to 20 weeks)

    Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNE is an 11 item self-report scale. Answers are on a 5 point Likert scale ranging from "I don't agree at all" to "I completely agree." Possible scores range from 11 to 55. Higher scores reflect better outcomes (i.e. more psychological needs being met through exercise).

    Measure: Mean Difference in Composite Score on the Basic Psychological Needs in Exercise Scale (BPNES)

    Time: Baseline and the last study visit (Up to 20 weeks)

    Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). 2. The PACES is an 18 item self-report scale. Answers are on a 7-point scale. Possible scores range from 18 to 126. Higher scores reflect better outcomes (greater enjoyment of physical activity).

    Measure: Mean Difference in Composite Score on the Physical Activity Enjoyment Scale (PACES)

    Time: Baseline and the last study visit (Up to 20 weeks)

    Description: Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNS is a 21 item self-report scale. Answer are on a 7-point Likert scale ranging from "not at all true" to "very true." Possible scores range from 21 to 147. Higher scores reflect better outcomes (better autonomy, competence, and relatedness).

    Measure: Mean Difference in Composite Score on the Basic Psychological Needs Scale (BPNS)

    Time: Baseline and the last study visit (Up to 20 weeks)

    Description: Mean difference in composite score from mid-treatment to last study visit (up to 20 weeks). The Autonomy Scale is a 6 item self-report scale. Answers are made using a 7-point scale. Possible scores range from 7 to 46. Higher scores reflect better outcomes (better relationship between research participant and staff.

    Measure: Mean Difference in Composite Score on the Autonomy Support Scale

    Time: Baseline and the last study visit (Up to 20 weeks)

    Description: Total score at Post treatment visit only (16 weeks). The End of Study survey measures participant's satisfaction and feedback with the PACE-Life trial. The survey is a 18 item self-report scale, consisting of both Likert scale and open-ended items. Answers are made using a 5-point Likert scale. Possible scores range from 18-90. Higher scores reflect higher levels of satisfaction and enjoyment in the study.

    Measure: End of Study Survey

    Time: Post treatment only (16 weeks)
    5 A Phase II, Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder

    This study will investigate the efficacy and safety of RO6889450 as monotherapy in participants experiencing an acute exacerbation of symptoms of schizophrenia or schizoaffective disorder.

    NCT04512066
    Conditions
    1. Schizophrenia, Schizoaffective Disorder
    Interventions
    1. Drug: RO6889450
    2. Drug: Placebo
    3. Drug: Risperidone
    MeSH:Schizophrenia Psychotic Disorders
    HPO:Psychosis Schizophrenia

    Primary Outcomes

    Measure: Change from Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score

    Time: Baseline to Week 4

    Secondary Outcomes

    Measure: Proportion of Participants with at least 20% or 50% Improvement from Baseline in the PANSS Total Score

    Time: Baseline to Week 12

    Measure: Change from Baseline in the PANSS Factor Scores

    Time: Baseline to Week 12

    Measure: Proportion of Participants with at Least 20% or 50% Improvement in the PANSS Factor Scores

    Time: Baseline to Week 12

    Measure: Change from Baseline in Clinical Global Impression Severity (CGI-S) Scores

    Time: Baseline to Week 12

    Measure: Clinical Global Impression - Improvement (CGI-I) Scores

    Time: Baseline to Week 12

    Measure: Clinical Global Impression - Improvement Most Troubling Symptoms (CGI-I MTS)

    Time: Baseline to Week 12

    Measure: Change from Baseline in Clinical Global Impression - Severity Most Troubling Symptoms (CGI-S MTS)

    Time: Baseline to Week 12

    Measure: Time from First Randomized Treatment Intake to Readiness for Discharge as Assessed by the Readiness for Discharge Questionnaire (RDQ)

    Time: Baseline to Week 4

    Measure: Percentage of Participants with Adverse Events (AEs)

    Time: Baseline to Week 12

    Measure: Change from Baseline in Electrocardiogram (ECG) Intervals

    Time: Baseline to Week 12

    Measure: Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time: Baseline to Week 12

    Measure: Change from Baseline in Extrapyramidal Symptom Rating Scale (ESRS-A)

    Time: Baseline to Week 12

    Measure: Maximum Concentration (Cmax) of RO6889450

    Time: Baseline to Week 12

    Measure: Area Under the Concentration-Time Curve at Steady State (AUCss) of RO6889450

    Time: Baseline to Week 4
    6 A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adults With DSM-5 Schizophrenia

    This is a Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multicenter inpatient study to examine the efficacy and safety of KarXT in adult subjects who are acutely psychotic with a Diagnostic and Statistical Manual Fifth Edition (DSM-5) diagnosis of schizophrenia. The primary objective of the study is to assess the efficacy of KarXT (a fixed combination of xanomeline 125 mg and trospium chloride 30 mg twice daily [BID]) versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a DSM-5 diagnosis of schizophrenia. The secondary objectives of the study are to evaluate improvement in disease severity and symptoms, safety and tolerability, and pharmacokinetics in adult inpatients with a DSM-5 diagnosis of schizophrenia.

    NCT04659161
    Conditions
    1. Schizophrenia
    2. Schizophrenia; Psychosis
    Interventions
    1. Drug: Xanomeline and Trospium Chloride Capsules
    2. Drug: Placebo
    MeSH:Schizophrenia
    HPO:Schizophrenia

    Primary Outcomes

    Description: The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.

    Measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5

    Time: Week 5

    Secondary Outcomes

    Description: The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. For positive symptoms in schizophrenia, participants are rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.

    Measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Week 5

    Time: Week 5

    Description: The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. For negative symptoms in schizophrenia, participants are rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.

    Measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Week 5

    Time: Week 5

    Description: The Negative Marder Factor score is derived from the PANSS and consists of the sum of 5 negative scales (N) and 2 general scales (G) (N1. Blunted affect; N2. Emotional withdrawal; N3. Poor rapport; N4. Passive/apathetic social withdrawal; N6. Lack of spontaneity; G7. Motor retardation; and G16. Active social avoidance), with a minimum score of 7 and a maximum score of 49.

    Measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Marder Factor Score

    Time: Week 5

    Description: The CGI-S modified asked the clinician 1 question: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants.

    Measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 5

    Time: Week 5

    Description: The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A PANSS responder is defined as a participant with at least a 30% change in PANSS total score compared to baseline at Week 5.

    Measure: Percentage of Positive and Negative Syndrome Scale (PANSS) responders (a 30% change in PANSS total score) at Week 5

    Time: Week 5
    7 An Open-label Extension Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in Subjects With DSM-5 Schizophrenia

    This is a Phase 3, multicenter, 53-week, outpatient, open-label extension (OLE) study to evaluate the long-term safety, tolerability, and efficacy of KarXT in subjects with Diagnostic and Statistical Manual-Fifth Edition (DSM-5) schizophrenia who previously completed the treatment period of one of the two Phase 3 double-blind studies, KAR-007 or KAR-009. In this OLE study, all subjects will receive KarXT (a fixed combination of xanomeline 125 mg and trospium chloride 30 mg twice daily [BID]) for up to 52 weeks regardless of treatment assignment in the preceding Phase 3 acute study. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with a DSM-5 diagnosis of schizophrenia. The secondary objective of this study is to assess the long-term efficacy and monitor trough concentrations of xanomeline and trospium after administration of KarXT.

    NCT04659174
    Conditions
    1. Schizophrenia
    Interventions
    1. Drug: Xanomeline and Trospium Chloride Capsules
    MeSH:Schizophrenia
    HPO:Schizophrenia

    Primary Outcomes

    Description: The number and percentage of participants with TEAEs will be determined

    Measure: Incidence of treatment-emergent adverse events (TEAEs)

    Time: From initial dose through 7 days after the final dose (up to 53 weeks)

    Secondary Outcomes

    Description: The number and percentage of participants with serious TEAEs will be determined

    Measure: Incidence of serious treatment-emergent adverse events (TEAEs)

    Time: From initial dose through 7 days after the final dose (up to 53 weeks)

    Description: The number and percentage of participants with TEAEs leading to withdrawal will be determined

    Measure: Incidence of treatment-emergent adverse events (TEAEs) leading to withdrawal

    Time: From initial dose through 7 days after the final dose (up to 53 weeks)

    Description: The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.

    Measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 52

    Time: Week 52

    Description: The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. For positive symptoms in schizophrenia, participants are rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.

    Measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Week 52

    Time: Week 52

    Description: The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. For negative symptoms in schizophrenia, participants are rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.

    Measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Week 52

    Time: Week 52

    Description: The Negative Marder Factor score is derived from the PANSS and consists of the sum of 5 negative scales (N) and 2 general scales (G) (N1. Blunted affect; N2. Emotional withdrawal; N3. Poor rapport; N4. Passive/apathetic social withdrawal; N6. Lack of spontaneity; G7. Motor retardation; and G16. Active social avoidance), with a minimum score of 7 and a maximum score of 49.

    Measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Marder Factor Score

    Time: Week 52

    Description: The CGI-S modified asked the clinician 1 question: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants.

    Measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 52

    Time: Week 52

    Description: The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A PANSS responder is defined as a participant with at least a 30% change in PANSS total score compared to baseline at Week 52.

    Measure: Percentage of Positive and Negative Syndrome Scale (PANSS) responders (a 30% change in PANSS total score) at Week 52

    Time: Week 52

    HPO Nodes


    Reports

    Data processed on December 13, 2020.

    An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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