Antidepressant Therapy in Treating Bipolar Type II Major Depression
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Purpose
This study will compare the safety and effectiveness of antidepressant therapy versus mood stabilizing therapy in treating people with bipolar type II major depression.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder Depression |
Drug: Venlafaxine Drug: Lithium Carbonate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Treatment of Bipolar Type II Major Depression |
- Reduction in Hamilton Depression rating score [ Time Frame: Measured at Weeks 12 and 36 ] [ Designated as safety issue: No ]
- Increase in Young Mania rating scale score [ Time Frame: Measured at Weeks 12 and 36 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: I
Antidepressant therapy
|
Drug: Venlafaxine
75 to 375 mg
|
|
Active Comparator: II
Mood stabilizer therapy
|
Drug: Lithium Carbonate
300 to 2400 mg
|
Detailed Description:
Bipolar type II (BP II) depression affects 2.5% of the U.S. adult population. People with BP II disorder do not experience the manic episodes that are characteristic of BP I disorder, but rather they experience more modest mood swings with a greater number of major depressive episodes (MDEs). These MDEs are associated with high rates of disease and death. The treatment of BP II depression remains a challenge for clinicians. Mood stabilizer (MS) monotherapy is the current recommended treatment for BD II MDE, but there is reason to believe that antidepressant drug (AD) monotherapy could also be an effective treatment. However, concerns over AD-induced manic switch episodes have limited the use of this treatment option. Preliminary studies using the ADs fluoxetine or venlafaxine have shown success in treating and lowering the manic switch rate of those with BP II MDE. This study will compare the safety and effectiveness of AD monotherapy versus MS monotherapy in treating people with BP II major depression.
Participation in this double-blind study will last up to 9 months. After screening, which includes a medical and psychiatric history review, a physical exam, an electrocardiogram (EKG) test, clinical laboratory tests, a urine-based drug test, and a pregnancy test if applicable, participants will be randomly placed into one of two treatment groups. Participants in the AD monotherapy group will be treated with venlafaxine, and participants in the MS monotherapy group will be treated with lithium. During the first 12 weeks, there will be a total of nine study visits lasting between 45 and 60 minutes. In these visits, participants will receive their study drug and will undergo various assessments, including a review of medication history and side effects, vital sign measurements, and questionnaires about depression and daily functioning. Blood samples will be taken at most visits.
Participants who respond well during the initial 12 weeks of therapy with either drug will have the option to continue treatment for 6 additional months. During this time, participants will continue their assigned treatment and will attend five monthly study visits that will repeat previous assessments and procedures.
For information on a related study, please follow this link:
http://clinicaltrials.gov/show/NCT00044616
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Meets DSM-IV criteria for Axis I bipolar II disorder
- Meets DSM-IV criteria for Axis I major depressive episode
- Score of 16 on 17-item HAM-D rating scale
- Not taking monoamine oxidase inhibitors (MAOI) for more than 2 weeks prior to study entry
- Willing to use an effective form of birth control throughout the study
Exclusion Criteria:
- History of mania
- Current primary Axis I diagnosis other than bipolar II disorder
- Alcohol or drug dependence within 3 months prior to study entry
- Contraindication to treatment with venlafaxine or lithium
- Unstable medical condition (e.g., thyroid disease, hypertension, or angina pectoris)
- Pregnant or breastfeeding
- Experiencing suicidal thoughts
- Requires hospitalization
- Requires concurrent neuroleptic or MS therapy
- Requires concurrent AD therapy
- Current psychotic features
- Inadequate trial of therapy at the time of initial screening visit
- History of intolerance to either venlafaxine or lithium
- Unlikely to participate in a 36-week trial
- Presence of apparent secondary gain
Contacts and Locations| Contact: Robert J. DeRubeis, PhD | 215-662-3462 | derubeis@psych.upenn.edu |
| Contact: Maryanne Giampapa, BBA | 215-662-2835 | mgiampap@mail.med.upenn.edu |
| United States, Pennsylvania | |
| Depression Research Unit - University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104-3309 | |
| Contact: Robert J. DeRubeis, PhD 215-662-3462 derubeis@psych.upenn.edu | |
| Contact: Maryanne Giampapa, BBA 215-662-2835 mgiampap@mail.med.upenn.edu | |
| Principal Investigator: Robert J. DeRubeis, PhD | |
| Principal Investigator: | Robert J. DeRubeis, PhD | University of Pennsylvania |
More Information
No publications provided
| Responsible Party: | Jay Amsterdam, Professor, University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00602537 History of Changes |
| Other Study ID Numbers: | R01 MH060353-02, R01MH060353-02, 2 R01 MH060353-06A2, DSIR 83 AT-P |
| Study First Received: | January 15, 2008 |
| Last Updated: | July 26, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Pennsylvania:
|
Bipolar Type II Disorder Hypomania Antidepressant Mood Stabilizer Venlafaxine |
Lithium Carbonate Major Depressive Episode Hypomanic Episodes Prevention of Depression Relapse |
Additional relevant MeSH terms:
|
Bipolar Disorder Depression Depressive Disorder Depressive Disorder, Major Affective Disorders, Psychotic Mood Disorders Mental Disorders Behavioral Symptoms 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