Relapse Prevention for Bipolar Type-II Disorder - Tabular View

Tracking Information
First Received Date ^ICMJE	September 3, 2002
Last Updated Date	February 19, 2009
Start Date ^ICMJE	February 2001
Primary Completion Date	January 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00044616 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Relapse Prevention for Bipolar Type-II Disorder
Official Title ^ICMJE	Relapse Prevention of Bipolar Type-II Disorder
Brief Summary	This 62-week study will compare the safety and effectiveness of fluoxetine (Prozac®), lithium, the combination of these two medications, and placebo in treating and preventing recurrent depressive episodes in people with bipolar type II disorder.
Detailed Description	Bipolar II (BP II) disorder is characterized by a high recurrence of major depressive episodes (MDE), and it is associated with substantial illness and deaths. Unfortunately, relatively little attention has been given to treatment of BP II. Concern that patients may switch from depressed to manic states during treatment of MDE has impeded the development of effective treatments for BP II MDE. BP II MDE patients are treated initially with fluoxetine for 10 weeks. Patients who recover from MDE are then randomized to receive a relapse-prevention treatment of fluoxetine, lithium, a combination of fluoxetine and lithium, or placebo for 1 year. Patients undergo clinical and laboratory evaluations, including physical examinations, bloodwork, thyroid function tests, electrocardiogram (ECG), urinalysis, and HAM-D, YMR, CGI-S, CGI-I, and adverse events scales. For information on a related study, please follow this link: http://clinicaltrials.gov/show/NCT00602537
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Bipolar Disorder Depression
Intervention ^ICMJE	Drug: Fluoxetine Drug: Lithium
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	180
Completion Date	January 2007
Primary Completion Date	January 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Bipolar II Depression
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00044616
Responsible Party
Study ID Numbers ^ICMJE	R01 MH060353-01, DSIR 83-ATP
Study Sponsor ^ICMJE	National Institute of Mental Health (NIMH)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Mental Health (NIMH)
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP