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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00602537 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Treatment of Bipolar Type II Major Depression |
| Estimated Enrollment: | 160 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
I: Experimental
Antidepressant therapy
|
Drug: Venlafaxine
75 to 375 mg
|
|
II: Active Comparator
Mood stabilizer therapy
|
Drug: Lithium Carbonate
300 to 2400 mg
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jay D. Amsterdam, MD | 215-662-3462 | jamsterd@mail.med.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: Jay D. Amsterdam, MD 215-662-3462 jamsterd@mail.med.upenn.edu | |
| Contact: Maryanne Giampapa, BBA 215-662-2835 mgiampap@mail.med.upenn.edu | |
| Principal Investigator: Jay D. Amsterdam, MD | |
| Principal Investigator: | Jay D. Amsterdam, MD | University of Pennsylvania |
More Information
| Responsible Party: | University of Pennsylvania ( Jay D. Amsterdam, MD ) |
| Study ID Numbers: | MH060353, 2 R01 MH060353-06A2, DSIR 83 AT-P |
| Study First Received: | January 15, 2008 |
| Last Updated: | August 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00602537 |
| Health Authority: | United States: Federal Government |
|
Bipolar Type II Disorder Hypomania Antidepressant Mood Stabilizer Venlafaxine |
Lithium Carbonate Major Depressive Episode Hypomanic Episodes Prevention of Depression Relapse |
|
Depression Bipolar Disorder Lithium Carbonate Depressive Disorder, Major Depressive Disorder Serotonin Behavioral Symptoms |
Affective Disorders, Psychotic Mental Disorders Venlafaxine Mood Disorders Psychotic Disorders Lithium |
|
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors Antimanic Agents |
Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Therapeutic Uses Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |
