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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02477670
Recruitment Status : Completed
First Posted : June 23, 2015
Last Update Posted : August 1, 2018
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: AVP-786 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of AVP-786 (Deuterated [d6]-Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) as an Adjunctive Treatment for Patients With Residual Schizophrenia.
Actual Study Start Date : September 2015
Actual Primary Completion Date : July 21, 2017
Actual Study Completion Date : July 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo capsules administered twice a day over a 12-week period
Drug: Placebo
Experimental: AVP-786
AVP-786 dose 2 capsules administered twice a day over a 12-week period
Drug: AVP-786

Primary Outcome Measures :
  1. NSA 16 [ Time Frame: 12 weeks ]
    16-Item Negative Symptom Assessment (NSA 16) total score.

Secondary Outcome Measures :
  1. PANSS [ Time Frame: 12 weeks ]
    Positive and Negative Syndrome Scale total score

  2. MCCB [ Time Frame: 12 weeks ]
    MATRICS Consensus Cognitive Battery (MCCB) composite score

  3. PGI-C [ Time Frame: 12 weeks ]
    Patient Global Impression of Change

  4. CDSS [ Time Frame: 12 weeks ]
    Calgary Depression Scale for Schizophrenia

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02477670

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United States, California
Cerritos, California, United States
Garden Grove, California, United States
National City, California, United States
Oakland, California, United States
San Diego, California, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Orlando, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Augusta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Massachusetts
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
United States, Michigan
Grand Rapids, Michigan, United States
United States, New Jersey
Marlton, New Jersey, United States
United States, New York
Jamaica, New York, United States
New York, New York, United States
Rochester, New York, United States
Sponsors and Collaborators
Avanir Pharmaceuticals

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Responsible Party: Avanir Pharmaceuticals Identifier: NCT02477670     History of Changes
Other Study ID Numbers: 15-AVP-786-202
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Keywords provided by Avanir Pharmaceuticals:
Negative Symptoms
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders