CompletedPhase 2

A Phase 2 Efficacy and Safety Study of TAK-063 in Participants With an Acute Exacerbation of Schizophrenia

United States164 participantsStarted 2015-07-01

Plain-language summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of TAK-063 compared with placebo in treatment of acutely exacerbated schizophrenia.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Is capable of understanding and complying with protocol requirements.
✓. The participants or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
✓. Has a primary diagnosis of schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition \[DSM-5\], 295.90) confirmed by clinical interview (Structured Clinical Interview for DSM-5 Clinical Trial Version \[SCID-5-CT\]). The participant's initial diagnosis must be greater than or equal to (\>=) 1 year from screening.
✓. Is a man or woman age 18 to 65, inclusive, at Screening.
✓. Male participant who is nonsterilized and sexually active with a female partner of child bearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
✓. Female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
✓. The participant's psychotic symptoms were exacerbated within 2 months (60 days) prior to Screening (example, aggravated delusion).
✓. Has a score of 5 (moderate severe) or higher in 3 or more items of the following Positive and Negative Symptom Scale (PANSS) items at Screening and Day 1: delusions (P1), conceptual disorganization (P2), hallucinations (P3), suspiciousness (P6), and unusual thought content (G9).

Exclusion criteria

✕. Has received any investigational compound within 30 days prior to Screening, or within 5 half-lives prior to screening, whichever is longer.
✕. Has received TAK-063 in a previous clinical study or as a therapeutic agent or has previously or is currently participating in this study or have participated in 2 or more clinical studies within 12 months prior to Screening.
✕. Has a decrease in the PANSS Total Score by 20 percent (%) or more at Baseline (Day 1) compared with that at Screening \[(PANSS Total Score at Screening- PANSS total score at Baseline)/(PANSS Total Score at Screening- 30)\]\*100 \>=20%\].
✕. Is an immediate family member, study site employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, and sibling) or may consent under duress.
✕. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality (other than the disease being studied), which may impact the ability of the participant to participate or potentially confound the study results.
✕. Has a history of severe head injury/traumatic brain injury, myocardial infarction or stroke.
✕. Has a known hypersensitivity to any component of the formulation of TAK-063 or the practice pills (i.e., small colored candies) during the AiCure device training.
✕. Has a positive urine drug result (illicit, illegal or without valid prescription or medical need) at Screening.

What they're measuring

Change From Baseline in the Positive and Negative Symptom Scale (PANSS) Total Score at Week 6

Timeframe: Baseline and Week 6

Trial details

NCT IDNCT02477020

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-07-13

Results submitted2017-07-12

View on ClinicalTrials.gov More Schizophrenia trials