Antidepressant Therapy in Treating Bipolar Type II Major Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert DeRubeis, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00602537
First received: January 15, 2008
Last updated: July 22, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Reduction in Hamilton Depression rating score [ Time Frame: Measured at Weeks 12 and 36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Increase in Young Mania rating scale score [ Time Frame: Measured at Weeks 12 and 36 ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: December 2007
Study Completion Date: June 2013
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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602537

Locations
United States, Pennsylvania
Depression Research Unit - University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-3309
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Robert J. DeRubeis, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Robert DeRubeis, 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 22, 2014
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
Depressive Disorder, Major
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Venlafaxine
Lithium Carbonate
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
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antidepressive Agents, Second-Generation
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014