Status:

COMPLETED

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

Lead Sponsor:

North Suffolk Mental Health Association

Collaborating Sponsors:

RespireRx

Conditions:

Schizophrenia

Eligibility:

18-65 years

Phase:

PHASE2

PHASE3

Brief Summary

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 modulat...

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

February 1 2002

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2007

Estimated Enrollment :

105 Patients enrolled

Trial Details

Trial ID

NCT00235352

Start Date

February 1 2002

End Date

February 1 2007

Last Update

February 26 2009

Active Locations (1)

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Freedom Trail Clinic

Boston, Massachusetts, United States, 02114