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Trial of Ampakine Added to Clozapine, Olanzapine or Risperidone in Patients With Schizophrenia

NCT ID: NCT00235352

Last Updated: 2009-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2007-02-28

Brief Summary

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The purpose of this study is to evaluate the effects of a four-week trial of CX516 900mg tid compared to placebo upon verbal memory, attention and negative symptoms. The AMPA receptor positive modulator, CX516, will be added to a stable dose of clozapine, olanzapine or risperidone in inpatients and outpatients with schizophrenia. The trial is intended to extend and replicate results from our previous placebo-controlled pilot trial of CX516 added to clozapine in which the investigators found improvement in memory and attention (moderate-to-large between group effect sizes) and did not observe serious side effects. Because the investigators' pilot trial also detected at two-week follow-up persistence of cognitive benefits and emergence of a large therapeutic effect upon negative symptoms, this trial will also repeat clinical and cognitive assessments at follow-up, four weeks after completion of the study medication to evaluate persistence and/or strengthening of effects.

Detailed Description

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Conditions

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Schizophrenia

Keywords

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Schizphrenia Cognition Negative Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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CX516 (Ampakine)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of Schizophrenia, any subtype
2. Ages 18-65 years
3. Capable of providing informed consent
4. Stable dose of clozapine, olanzapine or risperidone for at least 6 months

Exclusion Criteria

1. Serious medical or neurological illness (unstable cardiac disease, seizure disorder, malignancy, liver or renal impairment, etc.)
2. Current substance abuse
3. Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile
4. Unable to complete neuropsychological tests
5. History of serious blood dyscrasia requiring discontinuation of clozapine
6. Serious suicidal or homicidal risk within the past six months
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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RespireRx

INDUSTRY

Sponsor Role collaborator

North Suffolk Mental Health Association

OTHER

Sponsor Role lead

Responsible Party

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North Suffolk Mental Health Association

Principal Investigators

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Donald C Goff, MD

Role: PRINCIPAL_INVESTIGATOR

North Suffolk Mental Health Association

Locations

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Freedom Trail Clinic

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Goff DC, Lamberti JS, Leon AC, Green MF, Miller AL, Patel J, Manschreck T, Freudenreich O, Johnson SA. A placebo-controlled add-on trial of the Ampakine, CX516, for cognitive deficits in schizophrenia. Neuropsychopharmacology. 2008 Feb;33(3):465-72. doi: 10.1038/sj.npp.1301444. Epub 2007 May 9.

Reference Type RESULT
PMID: 17487227 (View on PubMed)

Other Identifiers

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IR43 MH59450

Identifier Type: -

Identifier Source: org_study_id