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Pharmacotherapy of Treatment-Resistant Mania

Information source: University of Pittsburgh
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mania

Intervention: Lithium (Drug); verapamil (Drug); verapamil plus lithium (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University of Pittsburgh

Official(s) and/or principal investigator(s):
Alan G. Mallinger, M.D., Principal Investigator, Affiliation: University of Pittsburgh

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.

Clinical Details

Official title: Pharmacotherapy of Treatment-Resistant Mania

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

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

Very much improved or much improved (compared to baseline) on the Clinical Global Impressions scale

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

University of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States
Additional Information

Related publications:

Frank E, Kupfer DJ, Gerebtzoff A, Meya U, Laghrissi-Thode F, Grochocinski VJ, Houck PR, Mallinger AG, Gibbons RD. The development of study exit criteria for evaluating antimanic compounds. J Clin Psychiatry. 2001 Jun;62(6):421-5.

Starting date: November 1994
Last updated: February 24, 2011

Page last updated: August 23, 2015

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