Clinical trial NCT00097942: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: memantine
adjunctive therapy
schizophrenia
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2004-12-02
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Positive and Negative Symptom Scale (PANSS) - Total Score
Secondary outcomes:
measure: Clinical Global Impression - Severity (CGI-S)
measure: PANNS - Positive Score
measure: PANSS - Negative Score
measure: Calgary Depression Scale for Schizophrenia
measure: Brief Assessment of Cognition
measure: Clinical Global Impression - Improvement
Other outcomes:
Locations:
city: National City
country: United States
facility: Synergy Clinical Research
state: California
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
city: Miami
country: United States
facility: University of Miami Jackson Memorial Hospital
state: Florida
city: Iowa City
country: United States
facility: University of Iowa Psychiatric Research
state: Iowa
city: Rockville
country: United States
facility: CBH Health, LLC
state: Maryland
city: St. Louis
country: United States
facility: Metropolitan Psychiatric Center
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical School
state: New Hampshire
city: Orangeburg
country: United States
facility: Nathan Kline Institute
state: New York
city: Butner
country: United States
facility: Duke University John Umstead Hospital
state: North Carolina
city: Raleigh
country: United States
facility: UNC - Chapel Hill, Clinical Research Unit
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Science Building
state: Ohio
city: Irving
country: United States
facility: University Hills Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Medication Research Clinic
state: Texas
Study officials:
References: