Treatment Resistant Bipolar Depression

This study has been terminated.
(Lundbeck withdrew committment - expiring patents and prolonged inactivity)
Sponsor:
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00272025
First received: January 3, 2006
Last updated: September 23, 2009
Last verified: September 2009

January 3, 2006
September 23, 2009
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 ] [ Designated as safety issue: No ]
To evaluate improvement
Complete list of historical versions of study NCT00272025 on ClinicalTrials.gov Archive Site
To evaluate efficacy, safety and tolerability of added Escitalopram, to a mood stabilizer or atypical antipsychotic. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
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
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00272025
PSIY-207-05
No
Roumen, Milev, Providence Care, Mental Health Services
Queen's University
Not Provided
Principal Investigator: Roumen V. Milev, MD Queen's University
Queen's University
September 2009

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