Mania
Conditions
Keywords
Bipolar Disorder, Mania, Antimanic, Verapamil, Lithium
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.
Interventions
DRUGLithium
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.
DRUGverapamil
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.
DRUGverapamil plus lithium
Sponsors
National Institute of Mental Health (NIMH)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed