Antidepressant Therapy for Bipolar II Major Depression

Bipolar Type II Disorder Clinical Trial

Official title:

Acute Antidepressant Therapy in Bipolar II Major Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00641927
• Other study ID #: 01-005
• Status: Completed
• Phase: Phase 4
• First received: March 18, 2008
• Last updated: March 18, 2008
• Start date: April 2002
• Est. completion date: October 2006

Study information

• Verified date: March 2008
• Source: Stanley Medical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Type II Disorder
• Depressive Disorder, Major

Intervention

Drug:
• Venlafaxine
37.5 mg - 375 mg daily, 12 Weeks
• Lithium Carbonate
300 mg - 2100 mg daily, 12 weeks

Locations

Country	Name	City	State
United States	Depression Research Unit, Department of Psychiatry, University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Stanley Medical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Hamilton Depression Rating Scale score.		12 Weeks	No
Secondary	Change in Young Mania Rating Scale score.		12 Weeks	Yes