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NCT00216281 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Clozapine Augmented by Atomoxetine Versus Clozapine Augmented by Placebo in Patients With Chronic Resistant Schizophrenia
A Phase 3 study, sponsored by Indiana University.
- Terminated
- Registry status
- Phase 3
- Development phase
- 126
- Enrollment target
NCT00216281: Clinical Trial Phase 3 study, sponsored by Indiana University.
NCT00216281 is a Phase 3 study that was terminated before completion, run by Indiana University. The registered enrollment target is 126 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00216281, a Phase 3 study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 126 participants
- Enrollment target
Study Summary
This is a randomized, placebo-controlled study to assess the efficacy and safety of ATX augmentation of CLZ as a treatment for the cognitive symptoms of schizophrenia. A total sample size of 126 subjects diagnosed with schizophrenia and being treated with the antipsychotic clozapine will undergo genotyping. These subjects will have an initial assessment at four weeks and regular follow-up assessments for a total period of 52 weeks. These subjects will be randomized to continued treatment with CLZ and augmentation with ATX or Placebo.
Primary Outcome
Via rating scales and cognitive measures, effects of CLZ and ATZ on congitive function will be assessed. A total of 126 suybjets diagnosed with Schizophrenia will be recruited, consented, and treated with CLZ and ATZ. They will undergo genetic testing for 31 mutations of CYP2D6 including gene duplication and deletion as well as, two mutations in CYP2C19.
Interventions
- DRUG Clozapine augmented with atomoxetine up to 40 mg or placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2005-09 |
| Est. Completion | 2008-09 |
| Phase | Phase 3 |
Why NCT00216281 stopped before completion
NCT00216281 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 1 intervention - of which Clozapine augmented with atomoxetine up to 40 mg or placebo is the first listed.
NCT00216281 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00216281 about?
NCT00216281 is a clinical study titled "Efficacy and Safety Study of Clozapine Augmented by Atomoxetine Versus Clozapine Augmented by Placebo in Patients With Chronic Resistant Schizophrenia". This is a randomized, placebo-controlled study to assess the efficacy and safety of ATX augmentation of CLZ as a treatment for the cognitive symptoms of schizophrenia. A total sample size of 126 subjects diagnosed with schizophrenia and being treated with the antipsychotic clozapine will undergo gen...
What is the current status of trial NCT00216281?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 126 participants. The study started on 2005-09. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00216281?
The interventions under investigation include: Clozapine augmented with atomoxetine up to 40 mg or placebo (DRUG).
Who is sponsoring clinical trial NCT00216281?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00216281's enrollment target sits among peer trials
126 1603rd of 2000 higher than 396 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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