CompletedPhase 4

Antidepressant Therapy in Treating Bipolar Type II Major Depression

United States140 participantsStarted 2007-12

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Depressive Relapse

Timeframe: Weeks 16, 20, 24, 30, 36

Trial details

NCT IDNCT00602537

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-06

Results submitted2016-11-10

View on ClinicalTrials.gov More Bipolar Disorder trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.