Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia (ADVANCE)

Acadia Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Pimavanserin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02970305

ACP-103-038

2016-003436-20 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 403 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

3. Has predominant negative symptoms according to predefined study criteria

4. 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

Exclusion criteria

1. Patient has a psychiatric disorder other than schizophrenia

2. 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

3. 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

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

5. Patient has a family or personal history or symptoms of long QT syndrome

6. Patient has been hospitalized due to inadequate family support or care at the patient's primary residence, during the 8 weeks prior to screening

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

Treatment:

Drug: Placebo