Pharmacotherapy of Treatment-Resistant Mania
Completed · Phase 3
Conditions studied: Mania
In brief
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.
Key facts
- Study ID
- NCT00518947
- Run by
- University of Pittsburgh
- People needed
- 45
- Starts
- 1994-11-01
- Expected to finish
- 1999-06-01
- Last updated by the study team
- 2011-02-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- To be eligible for the study, patients were required to have a lifetime diagnosis of bipolar 1 or schizoaffective disorder, a current manic episode meeting DSM-IV criteria, and ratings >/= 7 on the Raskin Severity of Mania Scale and >/= 15 on the Bech-Rafaelsen Mania Scale.
You may not qualify if…
- Patients were excluded if they had:
- A pattern of severe rapid-cycling in which the patient consistently failed to meet the duration criteria for discreet episodes of syndromal mania or depression according to DSM-IV
- Sustained drug or alcohol abuse within the past three years
- Schizophrenia
- Organic affective syndrome
- A presenting episode that was secondary to the effect of any pharmacologic agent
- The presence of significant medical illness that would preclude or unduly complicate the intended pharmacologic management of the episode
- In females, refusal to use appropriate contraception; or
- Pregnancy.
Where it is running
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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