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

NCT ID: NCT02477670

Last Updated: 2020-09-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-07-21

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

AVP-786

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

Group Type EXPERIMENTAL

AVP-786

Intervention Type DRUG

Interventions

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AVP-786

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Avanir Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cerritos, California, United States

Site Status

Garden Grove, California, United States

Site Status

National City, California, United States

Site Status

Oakland, California, United States

Site Status

San Diego, California, United States

Site Status

Washington D.C., District of Columbia, United States

Site Status

Orlando, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Augusta, Georgia, United States

Site Status

Chicago, Illinois, United States

Site Status

Boston, Massachusetts, United States

Site Status

Worcester, Massachusetts, United States

Site Status

Grand Rapids, Michigan, United States

Site Status

Marlton, New Jersey, United States

Site Status

Jamaica, New York, United States

Site Status

New York, New York, United States

Site Status

Rochester, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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15-AVP-786-202

Identifier Type: -

Identifier Source: org_study_id

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