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OpenTrials
Completed

NCT Number: NCT00235352

Trial of 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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Freedom Trail Clinic

Boston, Massachusetts, 02114, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

CX516 (Ampakine)

Drug

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

North Suffolk Mental Health Association

Other

Collaborators

  • RespireRx

Registry information

Official study title

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

Acronym: CX516

Important dates

Study start
2002
Primary completion
2005
Study completion
2007
First posted
Oct 10, 2005
Registry last updated
Feb 26, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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