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Trial of Ampakine Added to Clozapine, Olanzapine or Risperidone in Patients With Schizophrenia (CX516)

This study has been completed.
Sponsor:
Collaborator:
Cortex Pharmaceuticals
Information provided by:
North Suffolk Mental Health Association
ClinicalTrials.gov Identifier:
NCT00235352
First received: October 6, 2005
Last updated: February 25, 2009
Last verified: February 2009
History of Changes

October 6, 2005
February 25, 2009
February 2002
April 2005   (final data collection date for primary outcome measure)
  • 1. Evaluate the effects of a four-week trial of CX516 900 mg tid compared to placebo upon verbal memory and attention (DCPT, CVLT, Letter-number sequencing) assessed as part of a standard cognitive battery.
  • 2. Evaluate the effects of CX516 compared to placebo on negative symptoms measured by the SANS total score.
  • 3. Evaluate tolerability and adverse effects measured by the AIMS and SAFTEE Scales.
  • 4. Evaluate persistence and/or strengthening of effects 4 weeks after completion of the 4-week trial.
Same as current
Complete list of historical versions of study NCT00235352 on ClinicalTrials.gov Archive Site
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Trial of Ampakine Added to Clozapine, Olanzapine or Risperidone in Patients With Schizophrenia
A Placebo-Controlled Trial of CX516 (Ampakine) Added to Clozapine, Olanzapine or Risperidone in Patients With Schizophrenia

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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
Drug: CX516 (Ampakine)
Not Provided
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. Epub 2007 May 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
February 2007
April 2005   (final data collection date for primary outcome measure)

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
Not Provided
18 Years to 65 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00235352
IR43 MH59450
Yes
Donald Goff, MD, North Suffolk Mental Health Association
North Suffolk Mental Health Association
Cortex Pharmaceuticals
Principal Investigator: Donald C Goff, MD North Suffolk Mental Health Association
North Suffolk Mental Health Association
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP