NCT00235352

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for phase_2 schizophrenia

Timeline
Completed

Started Feb 2002

Longer than P75 for phase_2 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

February 26, 2009

Status Verified

February 1, 2009

Enrollment Period

3.2 years

First QC Date

October 6, 2005

Last Update Submit

February 25, 2009

Conditions

Schizophrenia

Keywords

SchizphreniaCognitionNegative Symptoms

Outcome Measures

Primary Outcomes (4)

  • 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.

Interventions

CX516 (Ampakine)DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Freedom Trail Clinic

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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. doi: 10.1038/sj.npp.1301444. Epub 2007 May 9.

    PMID: 17487227RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

1-(quinoxalin-6-ylcarbonyl)piperidine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Donald C Goff, MD

    North Suffolk Mental Health Association

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 6, 2005

First Posted

October 10, 2005

Study Start

February 1, 2002

Primary Completion

April 1, 2005

Study Completion

February 1, 2007

Last Updated

February 26, 2009

Record last verified: 2009-02

Locations

US(1)