Overview

This trial is active, not recruiting.

Condition cognitive impairment associated with schizophrenia
Treatments mem 3454, placebo for mem 3454
Phase phase 2
Sponsor Memory Pharmaceuticals
Start date December 2007
End date February 2009
Trial size 160 participants
Trial identifier NCT00604760, MEM 3454-101

Summary

To establish the proof of concept that MEM 3454, used as add-on pharmacotherapy, is a safe and effective treatment in patients with cognitive impairment associated with schizophrenia (CIAS).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
mem 3454
Capsule 5 mg once a day
(Experimental)
mem 3454
Capsule 15 mg once a day
(Experimental)
mem 3454
Capsule 50 mg once a day
(Placebo Comparator)
placebo for mem 3454
Capsule once a day

Primary Outcomes

Measure
Change from baseline in the total composite score of the MATRICS cognitive battery at week 8.
time frame: Change from baseline at wk 8.

Secondary Outcomes

Measure
Change from baseline in the total composite score of the MATRICS cognitive battery at Weeks 4 and 10
time frame: Change from baseline - weeks 4 and 10
Change from baseline on the various cognition tests at Weeks 4, 8 and 10
time frame: Change from baseline at Weeks 4, 8 and 10
Functional Assessments Change from baseline on the following tests at Week 8 and 10: UPSA-2 and PSP
time frame: Change from baseline at weeks 8 and 10
Adverse events
time frame: weeks 2, 4, 6, 8, 10

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - Diagnosis of schizophrenia (any subtype), assessed using a structured interview. - At least one month on the same dose of antipsychotic medication. - Clinically stable, as judged by the investigator, and in a non-acute phase for at least 12 weeks. - Able to provide informed consent. - Fluent in English. - Smokers and non-smokers. Exclusion Criteria: - First 3 years of schizophrenia diagnosis. - Current risk of suicide, or history of suicidal behavior within the last 6 months. - Hospitalized for psychiatric symptoms in the past 3 months. - Other psychiatric diagnoses. - Substance abuse/dependence (other than nicotine or caffeine) within the last 6 months according. - Nicotine replacement therapy, smoking cessation medications or remedies, including Varenicline (Chantix).

Additional Information

Official title A Phase 2a, Multi-Center, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MEM 3454 as Adjunctive Treatment in Combination With a Preexisting Antipsychotic in Patients With Cognitive Impairment Associated With Schizophrenia
Trial information was received from ClinicalTrials.gov and was last updated in December 2008.
Information provided to ClinicalTrials.gov by Memory Pharmaceuticals.