Clinical trial NCT02477670: Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Residual Schizophrenia
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Sequential Parallel Comparison Design (SPCD) 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Negative Symptoms
Schizophrenia
AVP-786
Lead sponsor: Avanir Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-06-23
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in the 16-Item Negative Symptom Assessment (NSA-16) Total Score at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
Secondary outcomes:
measure: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Change From Baseline in the PANSS Negative Subscale Score at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Change From Baseline in the PANSS Marder Negative Factor Score at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Change From Baseline in the PANSS Prosocial Factor Subscale Score at Week 6 at Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Change From Baseline in the PANSS Positive Subscale Score at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Change From Baseline in the PANSS General Psychopathology Subscale Score at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Change From Baseline in the PANSS Excitement Component Subscale Score at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Change From Baseline in the NSA-16 Communication Domain Score at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Change From Baseline in the NSA-16 Emotion/Affect Domain Score at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Change From Baseline in the NSA-16 Social Involvement Domain Score at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Change From Baseline in the NSA-16 Motivation Domain Score at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Change From Baseline in the NSA-16 Retardation Domain Score at Week 6 at Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Change From Baseline in the NSA-16 Global Negative Symptoms Score at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Change From Baseline in the NSA-16 Global Level of Functioning Score at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Change From Baseline in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite Score at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Mean Actual Clinical Global Impression of Severity (CGI-S) of Illness Score at Week 6 and Week 12
timeFrame: Week 6 (Stage 1); Week 12 (Stage 2)
measure: Mean Actual Clinical Global Impression of Change (CGI-C) Score at Week 6 and Week 12
timeFrame: Baseline, Week 6 (Stage 1), Week 12 (Stage 2)
measure: Mean Actual Patient Global Impression of Change (PGI-C) Score at Week 6 at Week 12
timeFrame: Baseline, Week 6 (Stage 1), Week 12 (Stage 2)
measure: Change From Baseline in the Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Change From Baseline in the Effort Expenditure for Reward Task (EEfRT) Score for Baseline Press Rate at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Change From Baseline in the EEfRT Score for Choice Reaction Time (RT) 1st 50 at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Change From Baseline in the EEfRT Score for Completed Tasks at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Change From Baseline in the EEfRT Score for 12% Probability-Proportion High Effort Opts at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Change From Baseline in the EEfRT Score for 50% Probability-Proportion High Effort Opts 1st 50 at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Change From Baseline in the EEfRT Score for 88% Probability-Proportion High Effort Opts 1st 50 at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Change From Baseline in the EEfRT Score for All-Proportion High Effort Opts 1st 50 at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Change From Baseline in the EEfRT Score for Difference - Proportion High Effort Opts 1st 50 at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Number of Participants With a Reduction of 20% or Greater in the PANSS Total Score at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
measure: Change From Baseline in the 4-Item NSA (NSA-4) Total Score at Week 6 and Week 12
timeFrame: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
Other outcomes:
Locations:
city: Cerritos
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: National City
country: United States
state: California
city: Oakland
country: United States
state: California
city: San Diego
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Grand Rapids
country: United States
state: Michigan
city: Marlton
country: United States
state: New Jersey
city: Jamaica
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
Study officials:
References: