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

December 5, 2008 updated by: Memory Pharmaceuticals

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Lemon Grove, California, United States, 91945
        • Telecare-Cresta Loma
      • Newport Beach, California, United States, 92663
        • Newport Bay Hospital
      • Oceanside, California, United States, 92056
        • Excell Research
      • Pasadena, California, United States, 91107
        • Pasadena Research Institute
      • Rosemead, California, United States, 91770
        • BHC Alhambra Hospital
      • San Diego, California, United States, 92123
        • California Clinical Trials Medical Group
      • Santa Ana, California, United States, 92701
        • Neuropsychiatric Research Center of Orange County
      • Santa Ana, California, United States, 92704
        • Coastal Communities Hospital
      • Torrance, California, United States, 90502
        • Collaborative Neuroscience Network, Inc.
    • Florida
      • Aventura, Florida, United States, 33180
        • Aventura Hospital
      • Fort Lauderdale, Florida, United States, 33301
        • Fort Lauderdale Hospital
      • Miami, Florida, United States, 33180
        • TuKoi Clinical Research
      • Miami, Florida, United States, 33180
        • Aventura Hospital
      • North Miami, Florida, United States, 33161
        • Scientific Clinical Research, Inc.
      • North Miami, Florida, United States, 33161
        • Professional Clinical Research, Inc. c/o Segal Institute for Clinical Research
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Atlanta Center for Medical Research
    • Illinois
      • Berwyn, Illinois, United States, 60402
        • Berwyn Rehabilitation Center
      • Hoffman Estates, Illinois, United States, 60169
        • Alexian Brothers Center for Psychiatric Research
      • Hoffman Estates, Illinois, United States, 60169
        • Alexian Brothers Behavioral Health Hospital
      • Hoffman Estates, Illinois, United States, 60169
        • Chinmay K. Patel, DO
      • Oak Brook, Illinois, United States, 60523
        • American Medical Research, Inc.
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Clinical Research Institute
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • Parkwood Behavioral Health System
    • Missouri
      • St. Louis, Missouri, United States, 63118
        • St. Louis Clinical Trials, LC
    • New Jersey
      • Willingboro, New Jersey, United States, 08046
        • CRI Worldwide, LLC
      • Willingboro, New Jersey, United States, 08046
        • CRI Worldwide, LLC at Lourdes Medical Center of Burlington County
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Sooner Clinical Research
    • Pennsylvania
      • Norristown, Pennsylvania, United States, 19401
        • Arthur P. Noyes Research Foundation
      • Philadelphia, Pennsylvania, United States, 19139
        • CRC Worldwide, LLC
    • South Carolina
      • Charleston, South Carolina, United States, 29405
        • Carolina Clinical Trials, Inc.
    • Tennessee
      • Madison, Tennessee, United States, 37115
        • Centerstone
      • Memphis, Tennessee, United States, 38117
        • Research Strategies of Memphis, LLC
      • Memphis, Tennessee, United States, 38119
        • Vogelfanger and Struble Clinic
      • Memphis, Tennessee, United States, 38133
        • Lakeside Behavioral Health System
      • Nashville, Tennessee, United States, 37212-8645
        • Vanderbilt Psychiatric Hospital
      • Nashville, Tennessee, United States, 37208
        • Centerstone - Ella Hayes Center
      • Nashville, Tennessee, United States, 37217
        • Centerstone - Frank Luton Center
    • Texas
      • Austin, Texas, United States, 78756
        • FutureSearch Trials
      • Austin, Texas, United States, 78745
        • Texas NeuroRehab Center, Pecos Unit
      • Austin, Texas, United States, 78754
        • Community Clinical Reserarch, Inc.
      • Irving, Texas, United States, 75062
        • University Hills Clinical Research
    • Virginia
      • Petersburg, Virginia, United States, 23805
        • Poplar Springs Hospital
      • Richmond, Virginia, United States, 23229
        • International Clinical Research Associates, LLC
    • Washington
      • Bothell, Washington, United States, 98011
        • Pacific Institute of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the total composite score of the MATRICS cognitive battery at week 8.
Time Frame: Change from baseline at wk 8.
Change from baseline at wk 8.

Secondary Outcome Measures

Outcome Measure
Time Frame
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 - 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
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
Change from baseline at weeks 8 and 10
Adverse events
Time Frame: weeks 2, 4, 6, 8, 10
weeks 2, 4, 6, 8, 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memory Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Anticipated)

February 1, 2009

Study Registration Dates

First Submitted

January 17, 2008

First Submitted That Met QC Criteria

January 29, 2008

First Posted (Estimate)

January 30, 2008

Study Record Updates

Last Update Posted (Estimate)

December 8, 2008

Last Update Submitted That Met QC Criteria

December 5, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEM 3454-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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