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

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ClinicalTrials.gov Identifier: NCT00235352
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : February 26, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
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 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 or disease Intervention/treatment Phase
Schizophrenia Drug: CX516 (Ampakine) Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2002
Primary Completion Date : April 2005
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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. 2. Evaluate the effects of CX516 compared to placebo on negative symptoms measured by the SANS total score.
  3. 3. Evaluate tolerability and adverse effects measured by the AIMS and SAFTEE Scales.
  4. 4. Evaluate persistence and/or strengthening of effects 4 weeks after completion of the 4-week trial.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00235352


Locations
United States, Massachusetts
Freedom Trail Clinic
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
North Suffolk Mental Health Association
RespireRx
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
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: February 26, 2009
Last Verified: February 2009

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Clozapine
Olanzapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
GABA Antagonists
GABA Agents