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NCT00518947 · ClinicalTrials.gov registry record · Phase 3
Pharmacotherapy of Treatment-Resistant Mania
A Phase 3 study of Mania, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 3
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT00518947: Completed Phase 3 study of Mania, sponsored by University of Pittsburgh.
NCT00518947 is a Phase 3 study of Mania that has completed, run by University of Pittsburgh. The registered enrollment target is 45 participants, below the 144-participant average among 5 other Mania trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00518947, a Phase 3 study of Mania, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
Verapamil has been found in some but not all studies to have antimanic activity. Therefore, we investigated the use of verapamil, alone or as an adjunctive treatment, in manic patients who did not respond to an initial adequate trial of lithium. Each study phase lasted three weeks. Subjects were treated openly with lithium in Phase 1 (n=45). Those who failed to respond were randomly assigned to double-blind treatment in Phase 2 with either verapamil (n=10) or continued lithium (n=8). Phase 2 responders were continued on the same medication in Phase 3. Phase 2 nonresponders (n=10) were assigned to combined verapamil/lithium in Phase 3.
Conditions Studied
Interventions
- DRUG Lithium
- DRUG verapamil
- DRUG verapamil plus lithium
Study Locations (1)
Pennsylvania
- University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 1994-11 |
| Est. Completion | 1999-06 |
| Phase | Phase 3 |
What the finished NCT00518947 record still lists
NCT00518947 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 144-participant average among 5 other Mania trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Mania appearing as the primary indexed condition, and to 3 interventions - of which Lithium is the first listed.
NCT00518947 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00518947 about?
NCT00518947 is a clinical study titled "Pharmacotherapy of Treatment-Resistant Mania". Verapamil has been found in some but not all studies to have antimanic activity. Therefore, we investigated the use of verapamil, alone or as an adjunctive treatment, in manic patients who did not respond to an initial adequate trial of lithium. Each study phase lasted three weeks. Subjects were tre...
What is the current status of trial NCT00518947?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 45 participants. The study started on 1994-11. Estimated completion is 1999-06.
What conditions does trial NCT00518947 study?
This clinical trial studies the following conditions: Mania.
What interventions are being tested in trial NCT00518947?
The interventions under investigation include: Lithium (DRUG), verapamil (DRUG), verapamil plus lithium (DRUG).
Who is sponsoring clinical trial NCT00518947?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00518947 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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