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

Memory Pharmaceuticals

Status and phase

Unknown

Phase 2

Conditions

Cognitive Impairment Associated With Schizophrenia

Treatments

Drug: MEM 3454

Drug: Placebo for MEM 3454

Study type

Interventional

Funder types

Industry

Identifiers

NCT00604760

MEM 3454-101

Details and patient eligibility

About

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).

Enrollment

160 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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).