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NCT00573417 · ClinicalTrials.gov registry record · Phase 4
A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia
A Phase 4 study, sponsored by North Suffolk Mental Health Association.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT00573417: Completed Phase 4 study, sponsored by North Suffolk Mental Health Association.
NCT00573417 is a Phase 4 study that has completed, run by North Suffolk Mental Health Association. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00573417, a Phase 4 study, has completed, sponsored by North Suffolk Mental Health Association.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
This pilot study is an eight-week, randomized, double-blind, placebo-controlled, escalating dose trial of the novel vigilance-promoting drug, modafinil, added to a stable dose of clozapine in 40 patients with schizophrenia or schizoaffective disorder. Modafinil will be initiated at 100 mg/d. After 2 weeks, the study drug may be increased to 200 mg/d and after 4 weeks, study drug may be increased to a maximum of 300 mg/d. Dose escalation will be based upon persistence of sedation versus emergence of side effects.
Interventions
- DRUG Placebo
- DRUG modafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2003-09 |
| Est. Completion | 2007-11 |
| Phase | Phase 4 |
What the finished NCT00573417 record still lists
NCT00573417 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00573417 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00573417 about?
NCT00573417 is a clinical study titled "A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia". This pilot study is an eight-week, randomized, double-blind, placebo-controlled, escalating dose trial of the novel vigilance-promoting drug, modafinil, added to a stable dose of clozapine in 40 patients with schizophrenia or schizoaffective disorder. Modafinil will be initiated at 100 mg/d. After 2...
What is the current status of trial NCT00573417?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2003-09. Estimated completion is 2007-11.
What interventions are being tested in trial NCT00573417?
The interventions under investigation include: Placebo (DRUG), modafinil (DRUG).
Who is sponsoring clinical trial NCT00573417?
This trial is sponsored by North Suffolk Mental Health Association, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00573417's enrollment target sits among peer trials
40 1397th of 2000 higher than 533 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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