Phase 2
N=23
A Randomized, Double-Blind, Placebo Controlled, Two-Period Cross-Over, Proof of Activity Study to Evaluate the Effects of TAK-041 on Motivational Anhedonia as Add-On to Antipsychotics in Participants With Stable Schizophrenia
Stable Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT03319953 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Change From Baseline in the Brief Assessment of Cognition in Schizophrenia (BACS) Composite Score at Second Testing After TAK-041 Administration — 29.72; 27.35; 27.89; 2.28 t-scale — p=0.2079
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TAK-041 (Drug); Placebo (Drug); Second Generation Antipsychotics (SGA) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Neurocrine Biosciences
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Brief Assessment of Cognition in Schizophrenia (BACS) Composite Score at Second Testing After TAK-041 Administration |
29.72; 27.35; 27.89; 2.28; 5.35; 1.31 | 0.2079 |
| PRIMARY Blood-Oxygen-Level-Dependent (BOLD) Signal in the Average Ventral Striatum (VS) Region of Interest (ROI) Activation in the Monetary Incentive Delay (MID) Reward Task at First Testing After TAK-041 Administration |
0.23; 0.23; 0.03 | 0.1706 |
| SECONDARY Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) |
57.1; 71.4; 53.3 | — |
| SECONDARY Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose |
0; 0; 0 | — |
| SECONDARY Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements At Least Once Post Dose |
0; 0; 6.7; 4.8; 0; 0 | — |
| SECONDARY Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) at Least Once Post Dose |
0; 0; 6.7; 10.5; 20.0; 13.3 | — |
| SECONDARY Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) |
3; 0; 1; 1; 0; 0 | — |
Summary
The purpose of the study is to determine whether motivation/reward deficits observed in schizophrenia are attenuated and whether cognitive impairment associated with schizophrenia is improved by add-on TAK-041 administration to antipsychotics in participants with stable schizophrenia.
Eligibility Criteria
Inclusion Criteria
- Is on a stable dose of antipsychotics for at least 2 months as documented by medical history and assessed by site staff (other than those on the excluded medication list).
- Meets schizophrenia criteria as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) by the Mini International Neuropsychiatric Interview (MINI).
- Have Positive and Negative Syndrome Scale (PANSS) total score less than or equal to ( =) 15 at screening and baseline (Day -1).
- Has stable Screening and baseline (Day-1) PANSS and NSFS total scores (less than [ upper limit of normal [ULN] for the respective serum chemistries) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBILI), alkaline phosphatase (ALP), γ-glutamyl transferase (GGT) confirmed upon repeat testing, 5'-nucleotidase (Screening only), and/or abnormal urine osmolality, confirmed upon repeat testing.
- Meets DSM-5 criteria for substance use disorder or history of alcohol abuse within 1 month prior to Screening Visit.
- Has a history of claustrophobia or inability to tolerate mock scanner environment during habituation/screening session.
- Fulfills any of the MRI contraindications on the site standard radiography screening document.
- Has a history in the last year from the randomization visit or is currently receiving treatment with clozapine.
- Has a current diagnosis of a significant psychiatric illness other than schizophrenia, per DSM-5 and is in an acute phase or episode.
- Has a risk of suicide according to the investigator's clinical judgment (example, per C-SSRS positive answers on questions 4 or 5 or has made a suicide attempt within 6 months prior to screening visit).
Data sourced from ClinicalTrials.gov (NCT03319953). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.