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NCT00235352 · ClinicalTrials.gov registry record · Phase 2
Trial of Ampakine Added to Clozapine, Olanzapine or Risperidone in Patients With Schizophrenia
A Phase 2 study, sponsored by North Suffolk Mental Health Association.
- Completed
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
NCT00235352 is a Phase 2 study that has completed, run by North Suffolk Mental Health Association. The registered enrollment target is 105 participants.
The verdict
NCT00235352, a Phase 2 study, has completed, sponsored by North Suffolk Mental Health Association.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
Study 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.
Interventions
- DRUG CX516 (Ampakine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2002-02 |
| Est. Completion | 2007-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00235352
The ClinicalTrials.gov registry entry for NCT00235352 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is North Suffolk Mental Health Association, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CX516 (Ampakine) is the first listed.
NCT00235352 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00235352 about?
NCT00235352 is a clinical study titled "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 ...
What is the current status of trial NCT00235352?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2002-02. Estimated completion is 2007-02.
What interventions are being tested in trial NCT00235352?
The interventions under investigation include: CX516 (Ampakine) (DRUG).
Who is sponsoring clinical trial NCT00235352?
This trial is sponsored by North Suffolk Mental Health Association, which has 11 total clinical trials registered on ClinicalTrials.gov.
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