Antidepressant Therapy in Treating Bipolar Type II Major Depression

Completed · Phase 4

Conditions studied: Bipolar Disorder, Depression

In brief

This study will compare the safety and effectiveness of antidepressant therapy versus mood stabilizing therapy in treating people with bipolar type II major depression.

Key facts

Study ID

NCT00602537

Run by

University of Pennsylvania

People needed

140

Starts

2007-12-01

Expected to finish

2013-06-01

Last updated by the study team

2017-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Depression Research Unit - University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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