Pharmacotherapy of Treatment-Resistant Mania

Phase 3

Completed

• Conditions: Mania
• Interventions: Drug: Lithium; Drug: verapamil; Drug: verapamil plus lithium

• Registration Number: NCT00518947
• Lead Sponsor: University of Pittsburgh

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1994-11
• Study Completion: 1999-06
• Study First Submitted: 2007-08-08
• Study First Submitted QC: 2007-08-20
• Study First Posted: 2007-08-21
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-24
• Last Update Posted: 2011-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• 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.

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Lithium	Continued-Lithium
2.	verapamil	Verapamil
3.	verapamil plus lithium	Verapamil plus Lithium

Primary Outcome Measures

Name	Time	Method
A > 50% reduction in Bech-Rafaelsen Mania Scale score (relative to the baseline score at the start of the phase), and, a total Bech-Rafaelsen Mania Scale score < 11	3 weeks
Very much improved or much improved (compared to baseline) on the Clinical Global Impressions scale	3 weeks

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States