Safety and Effectiveness of Antidepressant Therapy in Treating Bipolar Type II Major Depression - Full Text View

Sponsor:	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:	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:

MedlinePlus related topics: Antidepressants Bipolar Disorder Depression

Drug Information available for: Venlafaxine Venlafaxine hydrochloride Lithium carbonate Lithium citrate

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

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
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

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

Contacts

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

Locations

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

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Jay D. Amsterdam, MD

University of Pennsylvania

More Information

No publications provided

Responsible Party:	Jay D. Amsterdam, MD, University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00602537 History of Changes
Other Study ID Numbers:	R01 MH060353-02, 2 R01 MH060353-06A2, DSIR 83 AT-P
Study First Received:	January 15, 2008
Last Updated:	April 23, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antipsychotic Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on February 12, 2012