Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by:
North Suffolk Mental Health Association Identifier:
First received: October 6, 2005
Last updated: February 25, 2009
Last verified: February 2009
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
Drug: CX516 (Ampakine)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

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)

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00235352

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

Responsible Party: Donald Goff, MD, North Suffolk Mental Health Association Identifier: NCT00235352     History of Changes
Other Study ID Numbers: IR43 MH59450
Study First Received: October 6, 2005
Last Updated: February 25, 2009

Keywords provided by North Suffolk Mental Health Association:
Negative Symptoms

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin Antagonists
GABA Antagonists
GABA Agents
Dopamine Antagonists
Dopamine Agents processed this record on May 23, 2017