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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

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ClinicalTrials.gov Identifier: NCT00604760
Recruitment Status : Unknown
Verified December 2008 by Memory Pharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : January 30, 2008
Last Update Posted : December 8, 2008
Sponsor:
Information provided by:

Study Description
Brief 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).

Condition or disease Intervention/treatment Phase
Cognitive Impairment Associated With Schizophrenia Drug: MEM 3454 Drug: Placebo for MEM 3454 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : December 2007
Estimated Primary Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A Drug: MEM 3454
Capsule 5 mg once a day
Experimental: B Drug: MEM 3454
Capsule 15 mg once a day
Experimental: C Drug: MEM 3454
Capsule 50 mg once a day
Placebo Comparator: D Drug: Placebo for MEM 3454
Capsule once a day


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Adverse events [ Time Frame: weeks 2, 4, 6, 8, 10 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00604760


  Show 44 Study Locations
Sponsors and Collaborators
Memory Pharmaceuticals
More Information

Additional Information:
Publications:
Responsible Party: Amy S. Domanowski, Ph.D., Head Regulatory Affairs, Memory Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT00604760     History of Changes
Other Study ID Numbers: MEM 3454-101
First Posted: January 30, 2008    Key Record Dates
Last Update Posted: December 8, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
Schizophrenia
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs