Pharmacotherapy of Treatment-Resistant Mania (TRM)

University of Pittsburgh

Status and phase: Completed; Phase 3

Conditions: Mania

Treatments: Drug: Lithium; Drug: verapamil plus lithium; Drug: verapamil

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00518947

1R01MH050634

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups

1

Active Comparator group

Description:

Continued-Lithium

Treatment:

Drug: Lithium

2.

Experimental group

Description:

Verapamil

Treatment:

Drug: verapamil

3.

Experimental group

Description:

Verapamil plus Lithium

Treatment:

Drug: verapamil plus lithium