Last updated: March 30, 2017
Sponsor: Acadia
Overall Status: Active - Recruiting
Phase
3
Condition
N/ATreatment
N/AClinical Study ID
TX148415
All Genders
Study Summary
Eligibility Criteria
Inclusion
Main Inclusion Criteria
- > 18 years old
- Diagnosis of schizophrenia
- Must have caregiver identified for support and input throughout duration of trial
- Must have diagnosis > 1 year
- Must be predominantly negative symptoms and mild or less positive symptoms
- Cannot have had antipsychotic treatment for greater than 10 years
- Must be on one of the following background antipsychotics
- Aripiprazole
- Aripiprazole long acting injectables
- Abilify Maintena
- Aristada
- Asenapine
- Brexpiprazole
- Cariprazine
- Lurasidone
- Olanzapine
- Risperidone
- Risperidone long acting injection
- Must be on medication for 8 weeks with no recent dose changes
- Must be moderately ill and score moderate or higher on Delusions, Hallucinations, and Suspiciousness
- Medically stable
- BMI 19-34
Main
Exclusion
Exclusion Criteria
- Psychiatric disorder other than schizophrenia
- Currently moderately or higher depressive symptoms
- Currently at risk of suicide or danger to self or others
- Currently taking 3 or more antidepressants
- Substance use disorders in last 6 months
- Any positive UDS (including marijuana)
- Treatment with 2 or more antipsychotics
- History of diabetes
- Hep C, HIV
- Has participated in greater than 2 clinical trials in the last 2 years
Study Design
Study Start date:
March 30, 2017
Estimated Completion Date:
Study Description
Connect with a study center
Segal Institute for Clinical Research
Lauderhill, Florida 33319
United StatesActive - Recruiting
Segal Institute for Clinical Research
Charleston, South Carolina 29407
United StatesActive - Recruiting
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