Antidepressant Therapy for Bipolar II Major Depression
Information source: Stanley Medical Research Institute
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Type II Disorder
Intervention: Venlafaxine (Drug); Lithium Carbonate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Stanley Medical Research Institute Official(s) and/or principal investigator(s): Jay D Amsterdam, MD, Principal Investigator, Affiliation: Depression Research Unit, School of Psychiatry, University of Pennsylvania
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.
Clinical Details
Official title: Acute Antidepressant Therapy in Bipolar II Major Depression
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Reduction in Hamilton Depression Rating Scale score.
Secondary outcome: Change in Young Mania Rating Scale score.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Depression Research Unit, Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania 19104-3309, United States
Additional Information
Starting date: April 2002
Last updated: March 18, 2008
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