Pharmacotherapy of Treatment-Resistant Mania (TRM)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00518947
First received: August 8, 2007
Last updated: February 24, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Mania
Drug: Lithium
Drug: verapamil
Drug: verapamil plus lithium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacotherapy of Treatment-Resistant Mania

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 [ Time Frame: 3 weeks ]
  • Very much improved or much improved (compared to baseline) on the Clinical Global Impressions scale [ Time Frame: 3 weeks ]

Enrollment: 45
Study Start Date: November 1994
Study Completion Date: June 1999
Arms Assigned Interventions
Active Comparator: 1
Continued-Lithium
Drug: Lithium
Treatment with lithium carbonate was initiated at a dose of 900-1200 mg/day. Serum lithium levels were monitored twice weekly, and the dose was adjusted to attain target levels between 0.8 and 1.0 mmol/L by the end of week one, with subsequent levels as high as 1.4 mmol/L permitted if needed.
Experimental: 2.
Verapamil
Drug: verapamil
The initial dose of verapamil was 80 mg b.i.d., and this was raised by 80 mg/day every three days to a maximum of 480 mg/day, unless intolerable side effects were produced at a lower level, in which case the dose was maintained at the highest tolerated amount.
Experimental: 3.
Verapamil plus Lithium
Drug: verapamil plus lithium

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00518947

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Alan G. Mallinger, M.D. University of Pittsburgh
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00518947     History of Changes
Other Study ID Numbers: 1R01 MH50634
Study First Received: August 8, 2007
Last Updated: February 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Bipolar Disorder
Mania
Antimanic
Verapamil
Lithium

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Verapamil
Lithium
Lithium Carbonate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 27, 2014