A Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of 3 Dose Levels of TAK-831 in Adjunctive Treatment of Adult Participants With Negative Symptoms of Schizophrenia
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|ClinicalTrials.gov Identifier: NCT03382639|
Recruitment Status : Active, not recruiting
First Posted : December 26, 2017
Last Update Posted : September 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: TAK-831 Drug: Placebo||Phase 2|
The drug being tested in this study is called TAK-831. TAK-831 is being tested to treat negative symptoms in participants who have schizophrenia.
The study will enroll approximately 234 participants. Participants will then be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups in the double-blind period-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
- TAK-831 50 mg once daily
- TAK-831 125 mg once daily
- TAK-831 500 mg once daily
- Placebo once daily
This multi-center trial will be conducted in the United States, Spain, Italy, Czech Republic, Poland, Bulgaria and Ukraine. The overall time to participate in this study is approximately 20 weeks. Participants will make 11 visits to the clinic, and will be followed up for safety assessment 10 to 14 days after the last dose of study drug (Day 98).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||234 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 2, 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of 3 Dose Levels of TAK-831 in Adjunctive Treatment of Adult Subjects With Negative Symptoms of Schizophrenia|
|Actual Study Start Date :||January 4, 2018|
|Estimated Primary Completion Date :||March 11, 2021|
|Estimated Study Completion Date :||March 11, 2021|
Experimental: Double-blind: TAK-831 50 mg
TAK-831 50 milligram (mg), tablets, orally, once daily up to 14 weeks.
Experimental: Double-blind: TAK-831 125 mg
TAK-831 125 mg, tablets, orally, once daily up to 14 weeks.
Experimental: Double-blind: TAK-831 500 mg
TAK-831 500 mg, tablets, orally, once daily up to 14 weeks.
Placebo Comparator: Double-blind: Placebo
TAK-831 placebo-matching tablets, orally, once daily up to 14 weeks.
TAK-831 placebo-matching tablets.
- Change from Baseline on the PANSS NSFS at Day 84 [ Time Frame: Baseline and Day 84 ]PANSS assesses the positive symptoms, negative symptoms, and general psychopathology associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Negative subscale consists of 7 items which assess the negative symptoms with sub scale score ranging from 7 to 49, where higher score indicates greater severity.
- Change from Baseline on the PANSS NSFS at Days 28 and 56 [ Time Frame: Baseline, Days 28 and 56 ]PANSS assesses the negative symptoms associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Negative subscale consists of 7 items which assesses the negative symptoms with subscale score ranging from 7 to 49, where higher score indicates greater severity.
- Change from Baseline on the Brief Negative Symptom Scale (BNSS) at Day 84 [ Time Frame: Baseline and Day 84 ]The BNSS is a 13-item instrument designed for use in clinical trials and other studies that measures 5 domains of negative symptoms: blunted affect, alogia, asociality, anhedonia, and avolition. All the items in the BNSS are rated on a 7-point (0-6) scale, with anchor points generally ranging from the symptom's being absent (0) to severe (6). A scale total score is calculated by summing the 13 individual items; total score range of 0 to 78, where higher score indicates higher severity of negative symptoms.
- Change from Baseline on the Brief Assessment of Cognition in Schizophrenia (BACS) Composite Score at Day 84 [ Time Frame: Baseline and Day 84 ]The BACS is specifically designed to measure treatment-related improvements in cognition and includes alternate forms. BACS is a reliable and sensitive measure of cognitive function in schizophrenia. The BACS is a cognition assessment battery that assesses 6 domains of cognitive function found to be consistently impaired in schizophrenia: verbal memory, working memory, motor speed, attention, executive functions, and verbal fluency. 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.
- Change from Baseline on the Clinical Global Impression-Schizophrenia-Severity (CGI-SCH-S) Score at Day 84 [ Time Frame: Baseline and Day 84 ]The CGI-SCH scale is an adapted version of the CGI scale that is designed to assess global illness status in participant's with schizophrenia. CGI-SCH-S is a 7-point scale that requires the investigator to rate the severity of the participant's illness at the time of assessment. A participant is assessed on severity of mental illness on the following scale: 1. normal, not at all ill; 2. borderline ill; 3. mildly ill; 4. moderately ill; 5. markedly ill; 6. severely ill; or 7. extremely ill.
- Clinical Global Impression Schizophrenia Improvement (CGI-SCH-I) Score at Day 84 [ Time Frame: At Day 84 ]The CGI-SCH-I assesses the participant's improvement (or worsening). The investigator is required to assess the participant's condition relative to baseline on a 7-point scale where 1. very much improved; 2. much improved; 3. minimally improved; 4. no change; 5. minimally worse; 6. much worse; or 7. very much worse.
- Change from Baseline on the Schizophrenia Cognition Rating Scale (SCoRS) at Day 84 [ Time Frame: Baseline and Day 84 ]The SCoRS is an interview-based measure of cognitive functioning that is developed to specifically assess aspects of cognitive functioning in participants with schizophrenia. The items assess the 7 cognitive domains of attention, memory, reasoning and problem solving, working memory, processing speed, language functions, and social cognition. The SCoRS global total scores is the sum of the 20 items and it varies from 20 to 80 with 20 being the best outcome and 80 being the worst.
- Change from Baseline on the PANSS Total Score and Additional Subscales and Factors at Day 84 [ Time Frame: Baseline and Day 84 ]
- Plasma Concentrations of TAK-831 [ Time Frame: Day 1 pre-dose and at multiple time points (up to Day 84) post-dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382639
|Study Director:||Medical Director Clinical Science||Millennium Pharmaceuticals, Inc.|