Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that was terminated before completion, run by Indiana University. The registered enrollment target is 126 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00216281
The ClinicalTrials.gov registry entry for NCT00216281 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.