Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Residual Schizophrenia

Avanir Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: AVP-786

Study type: Interventional

Funder types: Industry

Identifiers

NCT02477670

15-AVP-786-202

Details and patient eligibility

About

The objectives of this 12-week study are to evaluate the efficacy, safety, and tolerability of AVP-786 as an adjunctive treatment compared with placebo in patients with residual schizophrenia.

Enrollment: 145 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who meet DSM-IV-TR diagnostic criteria for schizophrenia using the M.I.N.I. version 6.0.
• Patients must meet PANSS criteria
• Patients currently receiving atypical antipsychotics are eligible provided they are on a stable dose

Exclusion criteria

• Patients with current major depressive disorder (MDD)
• Patients with extrapyramidal syndrome secondary to their ongoing antipsychotic medication
• Patients currently using anticholinergic medications
• Recent in-patient hospitalization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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145 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo capsules administered twice a day over a 12-week period

Treatment:

Drug: Placebo

AVP-786

Experimental group

Description:

AVP-786 dose 2 capsules administered twice a day over a 12-week period

Treatment:

Drug: AVP-786