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Evaluation of the Safety and Efficacy of Memantine as Adjunctive Treatment in Schizophrenia Patients

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
memantine HCl
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring memantine, adjunctive therapy, schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: DSM-IV diagnosed Schizophrenia or schizoaffective disorder who are on a stable antipsychotic regimen with Brief Psychiatric Rating Scale (BPRS) total score greater than or equal to 26 and greater than or equal to 4 on at least one item Exclusion Criteria: Secondary diagnosis of Bipolar I disorder Suicidal history Organic brain disease Dementia History of substance abuse

Sites / Locations

  • Synergy Clinical Research
  • VA San Diego Healthcare System
  • University of Miami Jackson Memorial Hospital
  • University of Iowa Psychiatric Research
  • CBH Health, LLC
  • Metropolitan Psychiatric Center
  • Dartmouth Hitchcock Medical School
  • Nathan Kline Institute
  • Duke University John Umstead Hospital
  • UNC - Chapel Hill, Clinical Research Unit
  • University of Cincinnati Medical Science Building
  • University Hills Clinical Research
  • Medication Research Clinic

Outcomes

Primary Outcome Measures

Positive and Negative Symptom Scale (PANSS) - Total Score

Secondary Outcome Measures

Clinical Global Impression - Severity (CGI-S)
PANNS - Positive Score
PANSS - Negative Score
Calgary Depression Scale for Schizophrenia
Brief Assessment of Cognition
Clinical Global Impression - Improvement

Full Information

First Posted
December 1, 2004
Last Updated
March 1, 2012
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00097942
Brief Title
Evaluation of the Safety and Efficacy of Memantine as Adjunctive Treatment in Schizophrenia Patients
Official Title
A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine as Adjunctive Treatment to Atypical Antipsychotics in Schizophrenia Patients With Persistent Residual Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Forest Laboratories

4. Oversight

5. Study Description

Brief Summary
Standard antipsychotic drug regimens do not fully address the impact of cognitive symptoms associated with schizophrenia. The NMDA receptor has been connected to the pathophysiology of schizophrenia. Memantine is an uncompetitive NMDA receptor antagonist. It is hypothesized that adjunctive therapy with memantine will reduce NMDA receptor hyperactivity, improving signal to noise ratio and thereby improving cognitive symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
memantine, adjunctive therapy, schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
memantine HCl
Primary Outcome Measure Information:
Title
Positive and Negative Symptom Scale (PANSS) - Total Score
Secondary Outcome Measure Information:
Title
Clinical Global Impression - Severity (CGI-S)
Title
PANNS - Positive Score
Title
PANSS - Negative Score
Title
Calgary Depression Scale for Schizophrenia
Title
Brief Assessment of Cognition
Title
Clinical Global Impression - Improvement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DSM-IV diagnosed Schizophrenia or schizoaffective disorder who are on a stable antipsychotic regimen with Brief Psychiatric Rating Scale (BPRS) total score greater than or equal to 26 and greater than or equal to 4 on at least one item Exclusion Criteria: Secondary diagnosis of Bipolar I disorder Suicidal history Organic brain disease Dementia History of substance abuse
Facility Information:
Facility Name
Synergy Clinical Research
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
University of Miami Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Iowa Psychiatric Research
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
CBH Health, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Metropolitan Psychiatric Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63112
Country
United States
Facility Name
Dartmouth Hitchcock Medical School
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03755
Country
United States
Facility Name
Nathan Kline Institute
City
Orangeburg
State/Province
New York
ZIP/Postal Code
10962
Country
United States
Facility Name
Duke University John Umstead Hospital
City
Butner
State/Province
North Carolina
ZIP/Postal Code
27509
Country
United States
Facility Name
UNC - Chapel Hill, Clinical Research Unit
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27699-3601
Country
United States
Facility Name
University of Cincinnati Medical Science Building
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0559
Country
United States
Facility Name
University Hills Clinical Research
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
Medication Research Clinic
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States

12. IPD Sharing Statement

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Evaluation of the Safety and Efficacy of Memantine as Adjunctive Treatment in Schizophrenia Patients

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