Antidepressant Therapy for Bipolar II Major Depression
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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 |
- Reduction in Hamilton Depression Rating Scale score. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- 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 |
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| United States, Pennsylvania | |
| Depression Research Unit, Department of Psychiatry, University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104-3309 | |
| 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 May 16, 2013