Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 4 study that has completed, run by North Suffolk Mental Health Association. The registered enrollment target is 40 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00573417
The ClinicalTrials.gov registry entry for NCT00573417 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 40 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 2 interventions - of which Placebo is the first listed.
NCT00573417 reports 0 study locations.
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
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.