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Antidepressant Therapy in Treating Bipolar Type II Major Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00602537
First Posted: January 28, 2008
Last Update Posted: April 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pennsylvania
January 15, 2008
January 28, 2008
November 10, 2016
April 25, 2017
April 25, 2017
December 2007
June 2013   (Final data collection date for primary outcome measure)
Depressive Relapse [ Time Frame: Weeks 16, 20, 24, 30, 36 ]
These subjects must be responders. Outcome measures were obtained at continuation weeks. Participant would be considered "depressive relapse" if relapsed by any of these times.
Reduction in Hamilton Depression rating score [ Time Frame: Measured at Weeks 12 and 36 ]
Complete list of historical versions of study NCT00602537 on ClinicalTrials.gov Archive Site
Treatment-Emergent Mood Symptoms [ Time Frame: Measured at Weeks 12 and 36 ]
These subjects must be responders.
Increase in Young Mania rating scale score [ Time Frame: Measured at Weeks 12 and 36 ]
Not Provided
Not Provided
 
Antidepressant Therapy in Treating Bipolar Type II Major Depression
Treatment of Bipolar Type II Major Depression
This study will compare the safety and effectiveness of antidepressant therapy versus mood stabilizing therapy in treating people with bipolar type II major depression.

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

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Bipolar Disorder
  • Depression
  • Drug: Venlafaxine
    75 to 375 mg
  • Drug: Lithium Carbonate
    300 to 2400 mg
  • Experimental: I
    Antidepressant therapy
    Intervention: Drug: Venlafaxine
  • Active Comparator: II
    Mood stabilizer therapy
    Intervention: Drug: Lithium Carbonate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
June 2013
June 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00602537
R01MH060353-02( U.S. NIH Grant/Contract )
R01MH060353-02 ( U.S. NIH Grant/Contract )
2R01MH060353-06A2 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: No
University of Pennsylvania
University of Pennsylvania
National Institute of Mental Health (NIMH)
Principal Investigator: Robert J. DeRubeis, PhD University of Pennsylvania
University of Pennsylvania
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP