Treatment Resistant Bipolar Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00272025
Recruitment Status : Terminated (Lundbeck withdrew committment - expiring patents and prolonged inactivity)
First Posted : January 4, 2006
Last Update Posted : December 16, 2015
Information provided by (Responsible Party):
Dr. Roumen Milev, Queen's University

January 3, 2006
January 4, 2006
December 16, 2015
October 2006
January 2010   (Final data collection date for primary outcome measure)
To evaluate the response rates when Escitalopram vs. placeboes added to the current mood stabilizer or antipsychotic medication [ Time Frame: 6 weeks ]
To evaluate improvement
Complete list of historical versions of study NCT00272025 on Archive Site
To evaluate efficacy, safety and tolerability of added Escitalopram, to a mood stabilizer or atypical antipsychotic. [ Time Frame: 6 weeks ]
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Treatment Resistant Bipolar Depression
Six Week Double Blind, Randomized Trial of Escitalopram Add On for Treatment Resistant Bipolar Depression
To determine if adding Escitalopram to current mood stabilizer (MS) or atypical antipsychotic (AA) will improve in rates similar to or better than adding a placebo (inactive pill)in resistant bipolar patients.
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Bipolar Depression
  • Drug: Escitalopram
    10mg to 20mg tablet daily for 6 weeks
    Other Name: Cipralex
  • Drug: placebo
  • Active Comparator: 1
    There is a 50% chance of being randomized to Escitalopram in addition to current atypical antipsychotic (minimum dose risperidone 3mg, olanzapine 10mg or seroquel 400mg) or mood stabilizer (lithium, epival or lamotrigine)
    Intervention: Drug: Escitalopram
  • Placebo Comparator: 2
    to be filled in
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2010
January 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 or older
  • Diagnosis of Bipolar Disorder and currently be in depressive state, and not responded to mood stabilizer or atypical antipsychotic alone or combined with an antidepressant medication.

Exclusion Criteria:

  • Pregnant or breastfeeding
  • History of seizure disorder or other unstable medical condition
  • Received Electroconvulsive Therapy or Transcranial Magnetic Stimulation in the last three months
  • Experienced hallucinations or delusions
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Dr. Roumen Milev, Queen's University
Queen's University
Not Provided
Principal Investigator: Roumen V. Milev, MD Queen's University
Queen's University
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP