Antidepressant Therapy for Bipolar II Major Depression

This study has been completed.
Sponsor:
Information provided by:
Stanley Medical Research Institute
ClinicalTrials.gov Identifier:
NCT00641927
First received: March 18, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Bipolar Type II Disorder
Drug: Venlafaxine
Drug: Lithium Carbonate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acute Antidepressant Therapy in Bipolar II Major Depression

Resource links provided by NLM:


Further study details as provided by Stanley Medical Research Institute:

Primary Outcome Measures:
  • Reduction in Hamilton Depression Rating Scale score. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Young Mania Rating Scale score. [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: April 2002
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Antidepressant
Drug: Venlafaxine
37.5 mg - 375 mg daily, 12 Weeks
Other Name: Effexor-XR
Active Comparator: 2
Drug
Drug: Lithium Carbonate
300 mg - 2100 mg daily, 12 weeks
Other Name: Lithium

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641927

Locations
United States, Pennsylvania
Depression Research Unit, Department of Psychiatry, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-3309
Sponsors and Collaborators
Stanley Medical Research Institute
Investigators
Principal Investigator: Jay D Amsterdam, MD Depression Research Unit, School of Psychiatry, University of Pennsylvania
  More Information

No publications provided by Stanley Medical Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jay D. Amsterdam, MD, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00641927     History of Changes
Other Study ID Numbers: 01-005
Study First Received: March 18, 2008
Last Updated: March 18, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Stanley Medical Research Institute:
bipolar disorder
bipolar type II disorder
antidepressant
mood stabilizer
venlafaxine
lithium carbonate

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Lithium Carbonate
Venlafaxine
Lithium
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antimanic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on August 28, 2014