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TAK-831 500 mgWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)


Name (Synonyms) Correlation
drug2414 TAK-831 50 mg Wiki 1.00
drug1441 Matching Placebo Wiki 0.71

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D012559 Schizophrenia NIH 0.58

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0100753 Schizophrenia HPO 0.58

There is one clinical trial.

Clinical Trials


1 A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study to Evaluate Pharmacodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of TAK-831 in Adult Subjects With Schizophrenia

The purpose of this study is to determine whether TAK-831 is superior to placebo in improving cerebellar function as measured with the average percentage of conditioned responses during the eyeblink conditioning (EBC) test.

NCT03359785 Schizophrenia Drug: TAK-831 500 mg Drug: TAK-831 50 mg Drug: Matching Placebo
MeSH:Schizophrenia
HPO:Schizophrenia

Primary Outcomes

Description: EBC is a method used to investigate cerebellar function. In EBC, a conditioned stimulus (CS), a tone precedes but co-terminates with an unconditioned stimulus (US), an airpuff to the eyelid. Learning is demonstrated when an eyeblink (the conditioned response [CR]) occurs prior to the onset of the US. The percentage can range from 0% (no conditioned learning has occurred) to 100% (all responses are conditioned).

Measure: Average Percentage of Conditioned Responses During the Eye Blink Conditioning (EBC) Test at Day 8

Time: Day 8: For each treatment period

Secondary Outcomes

Description: MMN is an event related potential (ERP) evoked in response to unattended changes in background stimulation. MMN reflects an automatic process of detecting a mismatch between a deviant stimulus and a sensory-memory trace. Smaller amplitudes of MMN have been consistently identified in schizophrenia participants. MMN amplitude will be measured at Midline frontal electrode (Fz) of electroencephalogram [EEG].

Measure: Mean Mismatch Negativity (MMN) at Day 8

Time: Day 8: For each treatment period

Description: The P300 wave is an ERP component that is elicited by the presentation of a novel, behaviorally relevant target stimulus embedded among irrelevant stimuli in a manner similar to MMN, but requiring active listening and responding from participants. Auditory stimuli are presented in an oddball paradigm consisting of 1 standard tone and 1 target tone. Participants are instructed to push a button as quickly as possible when they hear the target tone, but not when they hear the standard tone. P300 reflects allocation of attention and activation of immediate memory. P300 amplitude indexes brain actions when the mental representation of the stimulus environment is updated, while P300 latency indexes stimulus classification speed unrelated to response selection processes. P300 amplitude will be measured at midline parietal electrode (Pz) of EEG.

Measure: Mean P300 Amplitude at Day 8

Time: Day 8: For each treatment period

Description: ASSR are evoked oscillatory responses that are entrained to the frequency and phase of temporally modulated stimuli. Individuals with schizophrenia experience subjective sensory anomalies and objective deficits on assessment of sensory function. These deficits can be produced by abnormal signaling in the sensory pathways and sensory cortex or by later-stage disturbances in the cognitive processing of such inputs. ASSR can be used to assess the integrity of sensory pathways including cortical processing. ASSR will be measured at midline central electrode (Cz) of EEG.

Measure: Mean Auditory Steady State Response (ASSR) to 40 Hz Stimulation at Day 8

Time: Day 8: For each treatment period

Description: BACS is specifically designed to measure treatment- related improvements in cognition and includes alternate forms. The battery of tests in the BACS includes brief assessments of reasoning and problem solving, verbal fluency, attention, verbal memory, working memory, and motor speed. The primary measure from each test of the BACS is standardized by creating z-scores whereby the mean of the test session of a healthy participant is set to 0 and the standard deviation set to 1. A composite score was calculated by averaging all of the 6 standardized primary measures from the BACS, and then calculating a z-score of the composite. The composite z-score indicates how much higher or lower the participant's cognition is compared to a healthy person.

Measure: Brief Assessment of Cognition in Schizophrenia (BACS) Cognitive Battery Composite Score at Day 7

Time: Day 7: For each treatment period

Measure: Mean Concentration of Plasma D-serine and L-serine Levels at Day 8

Time: Day 8: For each treatment period

Measure: Mean Plasma D-serine to Total Serine Ratio at Day 8

Time: Day 8: For each treatment period

Measure: Mean Plasma Concentration of TAK-831

Time: Day 1, 7 and 8: For each treatment period


Related HPO nodes (Using clinical trials)