Study to Evaluate the Safety and Efficacy of MEM 3454 as Adjunctive Treatment in Combination With… (NCT00604760) | Clinical Trial Compass
UnknownPhase 2
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
United States160 participantsStarted 2007-12
Plain-language 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).
Who can participate
Age range18 Years – 55 Years
SexALL
See this in plain English?
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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).
What they're measuring
1
Change from baseline in the total composite score of the MATRICS cognitive battery at week 8.