Antidepressant Therapy for Bipolar II Major Depression

NCT ID: NCT00641927

Last Updated: 2008-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2006-10-31

Brief Summary

This study examines the relative safety and benefit of antidepressant therapy (versus recommended mood stabilizer therapy)of bipolar type II major depressive episode. We hypothesize that antidepressant therapy will be superior to mood stabilizer therapy with little or no difference in treatment emergent manic symptoms.

Detailed Description

Bipolar type II (BP II) major depressive episode (MDE), affects 2.5% of the US adult population and results in an estimated healthcare cost of $40 billion annually. BP II disorder is a distinct clinical entity that differs from BP I disorder, and is characterized by a preponderance of MDEs that result in particularly high morbidity and mortality rates. The treatment of BP II MDE remains a challenge for clinicians. Concerns over antidepressant drug (AD) induced manic switch episodes have led current practice guidelines to recommend treating BP II MDE with mood stabilizer (MS) monotherapy and to avoid AD monotherapy. To date, there are no controlled clinical trials to test the validity of these empirical guidelines. Results from our preliminary BP II MDE studies have shown that fluoxetine monotherapy may be safe and effective initial treatment of BP II MDE with a low manic switch rate. Based upon these observations, we now ask (Specific aim #1): "What is the relative safety and efficacy of initial AD monotherapy vs. MS monotherapy of BP II MDE?" and "What is the relative manic switch rate of initial AD vs. MS monotherapy of BP II MDE?" To answer these questions, patients with BP II MDE will be treated in a 12-week, randomized, parallel group comparison of venlafaxine monotherapy vs. lithium monotherapy. We hypothesize that AD monotherapy will have superior efficacy vs. MS monotherapy, and that there will be a similar manic switch rate among both treatment conditions. If our hypotheses are correct, we believe that these results may have an important public health impact on the current practice guidelines for treating BP II MDE.

Conditions

Bipolar Type II Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Antidepressant

Group Type: EXPERIMENTAL

Venlafaxine

Intervention Type: DRUG

37.5 mg - 375 mg daily, 12 Weeks

2

Drug

Group Type: ACTIVE_COMPARATOR

Lithium Carbonate

Intervention Type: DRUG

300 mg - 2100 mg daily, 12 weeks

Interventions

Venlafaxine

37.5 mg - 375 mg daily, 12 Weeks

Intervention Type: DRUG

Lithium Carbonate

300 mg - 2100 mg daily, 12 weeks

Intervention Type: DRUG

Other Intervention Names

Effexor-XR; Lithium

Eligibility Criteria

Inclusion Criteria

• men and women (all races and ethnicity) greater than or equal to18 years of age,
• DSM IV diagnosis of BP II disorder,
• Current DSM IV MDE,
• HAM-D17 score greater than or equal to 16,
• Drug free from prior psychotropic medication greater than or equal to 7 days (2 weeks for MAOIs)

Exclusion Criteria

• History of mania,
• Other primary DSM IV Axis I diagnosis,
• Alcohol or drug dependence within 3 months,
• History of nonresponse to Effexor-XR or lithium in the present MDE,
• History of allergic reaction to Effexor-XR or lithium,
• Medical contraindications to treatment with Effexor-XR or lithium,
• Unstable medical condition,
• Pregnant or breast-feeding women,
• Women of child-bearing potential not using a medically approved form of contraception,
• Actively suicidal or requiring hospitalization,
• Requiring concurrent antidepressant, neuroleptic or mood stabilizer therapy,
• Prior investigational study within 4 weeks of starting active therapy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanley Medical Research Institute

OTHER

Sponsor Role: lead

Responsible Party

University of Pennsylvania

Principal Investigators

Jay D Amsterdam, MD

Role: PRINCIPAL_INVESTIGATOR

Depression Research Unit, School of Psychiatry, University of Pennsylvania

Locations

Depression Research Unit, Department of Psychiatry, University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

Shults J, Sun W, Tu X, Kim H, Amsterdam J, Hilbe JM, Ten-Have T. A comparison of several approaches for choosing between working correlation structures in generalized estimating equation analysis of longitudinal binary data. Stat Med. 2009 Aug 15;28(18):2338-55. doi: 10.1002/sim.3622.

Reference Type: DERIVED

PMID: 19472307 (View on PubMed)

Other Identifiers

01-005

Identifier Type: -

Identifier Source: org_study_id