NCT00044616

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2001

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2002

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

October 6, 2015

Status Verified

December 1, 2013

Enrollment Period

5.9 years

First QC Date

September 3, 2002

Last Update Submit

October 2, 2015

Conditions

Bipolar DisorderDepression

Interventions

FluoxetineDRUG
LithiumDRUG

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bipolar II Depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Depression Research Unit, Univ Penn

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • Amsterdam JD, Luo L, Shults J. Efficacy and mood conversion rate during long-term fluoxetine v. lithium monotherapy in rapid- and non-rapid-cycling bipolar II disorder. Br J Psychiatry. 2013 Apr;202(4):301-6. doi: 10.1192/bjp.bp.111.104711. Epub 2012 Oct 25.

    PMID: 23099447DERIVED

  • Amsterdam JD, Shults J. Efficacy and safety of long-term fluoxetine versus lithium monotherapy of bipolar II disorder: a randomized, double-blind, placebo-substitution study. Am J Psychiatry. 2010 Jul;167(7):792-800. doi: 10.1176/appi.ajp.2009.09020284. Epub 2010 Apr 1.

    PMID: 20360317DERIVED

MeSH Terms

Conditions

Bipolar DisorderDepression

Interventions

FluoxetineLithium

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsMetals, AlkaliElementsInorganic ChemicalsMetals, LightMetals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2002

First Posted

September 5, 2002

Study Start

February 1, 2001

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

October 6, 2015

Record last verified: 2013-12

Locations

US(1)