Pharmacotherapy of Treatment-Resistant Mania

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-11-30

Study Completion Date

1999-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment of Mania Symptoms With Drug Therapy

NCT00183443

Bipolar Disorder Schizophrenia

COMPLETED PHASE3

Antidepressant Therapy for Bipolar II Major Depression

NCT00641927

Bipolar Type II Disorder

COMPLETED PHASE4

3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects

NCT00312494

Bipolar Disorder

COMPLETED PHASE3

Effectiveness of Lithium and Valproate in Treating High-Risk Bipolar Disorder

NCT00563992

Bipolar Disorder

COMPLETED PHASE1

To Evaluate the Effects of NMRA-335140 on Symptoms of Major Depression in Participants With Bipolar II Disorder.

NCT06429722

Major Depressive Episode Associated With Bipolar II Disorder

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mania

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Continued-Lithium

Group Type ACTIVE_COMPARATOR

Lithium

Intervention Type DRUG

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.

2.

Verapamil

Group Type EXPERIMENTAL

verapamil

Intervention Type DRUG

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.

3.

Verapamil plus Lithium

Group Type EXPERIMENTAL

verapamil plus lithium

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

verapamil plus lithium

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No