Antidepressant Therapy in Treating Bipolar Type II Major Depression - Full Text View

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:

MedlinePlus related topics: Antidepressants

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

U.S. FDA Resources

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 (Adult, Senior)
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

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Robert J. DeRubeis, PhD	University of Pennsylvania

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Amsterdam JD, Lorenzo-Luaces L, Soeller I, Li SQ, Mao JJ, DeRubeis RJ. Safety and effectiveness of continuation antidepressant versus mood stabilizer monotherapy for relapse-prevention of bipolar II depression: A randomized, double-blind, parallel-group, prospective study. J Affect Disord. 2015 Oct 1;185:31-7. doi: 10.1016/j.jad.2015.05.070. Epub 2015 Jun 26.


Responsible Party:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00602537 History of Changes
Other Study ID Numbers:	R01MH060353-02 2R01MH060353-06A2
Study First Received:	January 15, 2008
Last Updated:	August 29, 2016
Health Authority:	United States: Federal Government
Individual Participant Data
Plan to Share IPD:	No

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:


Depression Depressive Disorder Bipolar Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Bipolar and Related Disorders Antidepressive Agents Lithium Carbonate Venlafaxine Hydrochloride Psychotropic Drugs	Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Neurotransmitter Agents Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on September 23, 2016