Antidepressant Therapy for Bipolar II Major Depression

Stanley Medical Research Institute

Status and phase

Completed

Phase 4

Conditions

Bipolar Type II Disorder

Treatments

Drug: Lithium Carbonate

Drug: Venlafaxine

Study type

Interventional

Funder types

Other

Identifiers

NCT00641927

01-005

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.