A study to evaluate the efficacy, safety and tolerability of TAK-831 in patients with schizophrenia
- Conditions
- SchizophreniaMedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
- Registration Number
- EUCTR2017-003471-54-IT
- Lead Sponsor
- MILLENNIUM PHARMACEUTICALS, INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 234
Male and female subjects from 18 to 50 60 years of age included.
• Subjects receiving primary primary antipsychotic therapy at a total daily dose of 2 to 6 mg of risperidone equivalents or its equivalent (as described in a Reference Document on equivalent doses of antipsychotics provided to centers). The concomitant treatment with a subtherapeutic dose of a second antipsychotic could be admitted, with the approval of the sponsor or a person in charge, if used as a hypnotic (to a maximum of 100 mg of quetiapine or its equivalent once a day before going to sleep [QHS]), but not if used for refractory positive psychotic symptoms. Within this exception, the total daily dose of the second antipsychotic should not be included in the calculation of the 6 mg / day limit of the risperidone equivalent.
• Subjects treated with a stable regimen of psychotropic drugs without clinically significant changes (no dose increase, reduction <250% of the dose due to tolerability) in the 2 months prior to the screening visit and no dose adjustment is planned for the entire duration of participation in the study up to Day 84 / Early termination visit.
• Subjects with a total BNSS score (12 items, excluding number 4) =28; stable scores at Run-in with single-blind placebo and total BNSS (at 12 items, excluding item 4) at baseline (variation =20% compared to Screening scores).
• Subjects who have a moderate to severe (=5) assessment of the PANSS items related to positive symptoms P1, P3, P4, P5, P6 or unusual thought content (G9), with a maximum of 2 of these item with a rating of 5; assessment not higher than moderate (=4) for conceptual disorganization (P2). Subjects should also have stable scores in the Single-blind and Basal placebo period (variation =20% compared to the Screening score) in all of these PANSS items.
• Subjects with evidence of stable symptomatology =3 months prior to the screening visit (eg no admission for schizophrenia, no access to the emergency room for symptoms of schizophrenia, no increase in the level of psychiatric treatment due to worsening of symptoms of schizophrenia).
• Subjects must have an adult informant (eg family member, social worker, social worker, protected facility personnel or nurse who spends =4 hours / week with the subject) who is deemed reliable by the investigator and is able to provide information for the compilation of the evaluation scales of the study, such as the PANSS and the SCoRS.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 234
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• The subject has a lifetime diagnosis of schizoaffective disorder; a lifetime diagnosis of bipolar disorder; or a lifetime diagnosis of obsessive compulsive disorder based on the MINI combined with the general psychiatric evaluation. As an exception, subjects with a historical prior lifetime diagnosis of schizoaffective disorder may be enrolled in the study with sponsor or designee approval provided that the principal investigator can attest that the subject’s overall history and current clinical presentation and history is most consistent with schizophrenia, not schizoaffective disorder.
• The subject has a recent (within the last 6 months) diagnosis of panic disorder, depressive episode, or other comorbid psychiatric conditions requiring clinical attention based on the MINI for DSM-5 and the general psychiatric evaluation.
• The subject has a diagnosis of substance use disorder (with the exception of nicotine dependence) within the preceding 6 months based on the MINI for DSM-5 and the general psychiatric evaluation.
• The subject is participating in a formal structured nonpharmacological therapeutic treatment program (cognitive remediation, cognitive-behavioral therapy, intensive symptom/vocational rehabilitation) for <3 months prior to randomization. In addition, initiation of such nonpharmacological treatment programs is not permitted during study participation through the Day 84 Visit.
• The subject exhibits more than a minimal level of antipsychotic-induced parkinsonism symptoms, as documented by a score on the modified Simpson Angus Scale (SAS) (excluding item number 10, Akathisia) >6.
• The subject has evidence of depression as measured by a Calgary Depression Scale Score (CDSS) >9.
• The subject's diagnosis of schizophrenia occurred prior to 12 years of age.
• The subject has a history of developmental intellectual disability or mental retardation.
• Antipsychotic plasma levels for the subject’s primary background antipsychotic are below the minimum acceptable concentration criteria per the Antipsychotic Drug Level Reference Document at the Screening or Placebo Run-in Visits. This criterion is not applicable to subjects on a primary background antipsychotic for which a clinical assay is unavailable (ie, not listed in the Antipsychotic Drug Level Reference Document).
• The subject has received clozapine for the treatment of schizophrenia within a 5-year period before Screening.
• The subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the subject has attempted suicide within the past year prior to Screening. Subjects who have positive answers on item number 4 or 5 on the C-SSRS (based on the past year) prior to randomization are excluded.
• The subject has a history of brain trauma associated with loss of consciousness for >15 minutes.
• The subject has received electroconvulsive therapy within 6 months (180 days) before Screening.
• The subject does not have a stable residence or is homeless.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method