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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
  Purpose

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.


Condition Intervention Phase
Schizophrenia
 Drug: CX516 (Ampakine)
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled Trial of CX516 (Ampakine) Added to Clozapine, Olanzapine or Risperidone in Patients With Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Memory Schizophrenia
U.S. FDA Resources

Further study details as provided by North Suffolk Mental Health Association:

Primary Outcome Measures:
  • 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.

Enrollment: 105
Study Start Date: February 2002
Study Completion Date: February 2007
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235352

Locations
United States, Massachusetts
Freedom Trail Clinic
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
North Suffolk Mental Health Association
Cortex Pharmaceuticals
Investigators
Principal Investigator: Donald C Goff, MD North Suffolk Mental Health Association
  More Information

Publications:

Responsible Party: Donald Goff, MD, North Suffolk Mental Health Association
ClinicalTrials.gov Identifier: NCT00235352     History of Changes
Other Study ID Numbers: IR43 MH59450
Study First Received: October 6, 2005
Last Updated: February 25, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by North Suffolk Mental Health Association:
Schizphrenia
Cognition
Negative Symptoms

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Clozapine
Risperidone
Olanzapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
GABA Antagonists
GABA Agents
Dopamine Antagonists
Dopamine Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 18, 2013