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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: Completed Phase 2 study, sponsored by North Suffolk Mental Health Association.

NCT00235352 is a Phase 2 study that has completed, run by North Suffolk Mental Health Association. The registered enrollment target is 105 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 105 participants
Start Date 2002-02
Est. Completion 2007-02
Phase Phase 2

What the finished NCT00235352 record still lists

NCT00235352 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower).

The record links to 0 conditions, and to 1 intervention - of which CX516 (Ampakine) is the first listed.

NCT00235352 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00235352's enrollment target sits among peer trials

105 650th of 2000 higher than 1,341 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00235352, the US trial registry maintained by the National Library of Medicine. NCT00235352 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.