Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1)

Acadia Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Pimavanserin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02970292

2016-003434-24 (EudraCT Number)

ACP-103-034

Details and patient eligibility

About

To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of schizophrenia

Enrollment: 396 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults patients, between 18 and 55 years of age

2. A clinical diagnosis of schizophrenia with a minimum duration of 1 year

3. The main background antipsychotic with which the subject is being treated must be one of the antipsychotics listed below:

   • Aripiprazole

   • Aripiprazole long-acting injectables:

     • Abilify Maintena®
     • Aristada®

   • Risperidone

   • Risperidone long-acting injection

   • Olanzapine

   • Lurasidone

   • Cariprazine

   • Brexpiprazole

   • Asenapine

4. Has had a partial but inadequate response to antipsychotic treatment

5. Has a history of response to antipsychotic treatment other than clozapine

Exclusion criteria

1. Patient has a psychiatric disorder other than schizophrenia

2. Patient has a history of resistance to antipsychotic treatment

3. A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse, except marijuana

   a. Patients with a result indicating the presence of marijuana are permitted if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation

4. Patient has current evidence of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program

5. Patient has had a myocardial infarction in the last six months

6. Patient is taking a medication or drug that prolongs the QT interval or has a family or personal history or symptoms of long QT syndrome

Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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396 participants in 2 patient groups, including a placebo group

Pimavanserin

Experimental group

Description:

Drug- pimavanserin 34 mg, 20 mg, or 10 mg taken as two tablets + background antipsychotic, once daily by mouth

Treatment:

Drug: Pimavanserin

Placebo

Placebo Comparator group

Description:

Placebo + background antipsychotic, taken as two tablets, once daily by mouth

Treatment:

Drug: Placebo