Study to Determine the Safety, Tolerability, and Efficacy of Evenamide in Patients With Chronic S… (NCT04461119) | Clinical Trial Compass
CompletedPhase 2
Study to Determine the Safety, Tolerability, and Efficacy of Evenamide in Patients With Chronic Schizophrenia
United States, India138 participantsStarted 2020-06-16
Plain-language summary
This 4-week study will evaluate the safety, tolerability and preliminary evidence of efficacy of evenamide (7.5,and 15 mg and placebo, bid) treatment in outpatients with chronic schizophrenia.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Demographics
* Age - 18 years, or older
* Sex - male, or non-childbearing potential female unless practicing adequate contraception
Psychiatric
* Has a current diagnosis of schizophrenia in accordance with DSM-5.
* Has been treated with antipsychotics for at least 2 years.
* Has a total score on the PANSS \< 80.
* Has a Clinical Global Impression - Severity of disease (CGI-S) rating of mildly, moderately or moderately severely ill (score of 3, 4 or 5).
* Needs antipsychotic treatment and is currently receiving a stable dose (minimally for 4 weeks prior to screening) of aripiprazole, clozapine, quetiapine, olanzapine, paliperidone, or risperidone (at least 2 mg risperidone dose-equivalent)
* Current symptoms have been stably present for at least one month
Procedural
* Patient resides at home or in a residential care facility
* If taking clozapine, patient agrees to blood monitoring
Exclusion Criteria:
Psychiatric
* Severity of current episode of psychosis requires that the patient be hospitalized. Patients who are chronically hospitalized or in psychiatric day-care, whose hospitalization is for logistic reasons and not due to the severity of their illness, will be eligible for the study.
* Severity of psychosis is rated severe or higher (CGI-S of 6 or greater).
* Known suicidal risk. A "yes" response on the C-SSRS Suicidal Ideation Item 4 or Item 5, or a "yes" response on any of the five C-SSRS Suicidal Behavior items, at screening, or a suicide at…
What they're measuring
1
Safety and tolerability - incidence of Treatment-Emergent Adverse Events [TEAEs], Serious Adverse Events [AEs], and Adverse Events leading to discontinuation [ADOs]
Timeframe: 4 Week study
2
Change from baseline in Positive and Negative Syndrome Scale [PANSS] total score