Treatment Resistant Bipolar Depression

Verified by: Queen's University, September 2009
First Received: January 3, 2006 | Last Updated: September 23, 2009 | Phase: Phase 1 | Start Date: October 2006
Overall Status: Terminated | Estimated Enrollment: 1
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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...

Brief Summary

Official Title: “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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: January 2010

Intervention(s) in this Clinical Trial

  • Drug: Escitalopram
    • 10mg to 20mg tablet daily for 6 weeks
  • Drug: placebo

Arms, Groups and Cohorts in this Clinical Trial

  • 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)
  • Placebo Comparator: 2

Outcome Measures for this Clinical Trial

Primary Measures

  • To evaluate the response rates when Escitalopram vs. placeboes added to the current mood stabilizer or antipsychotic medication
    • Time Frame: 6 weeks
      Safety Issue?: No

Secondary Measures

  • To evaluate efficacy, safety and tolerability of added Escitalopram, to a mood stabilizer or atypical antipsychotic.
    • Time Frame: 6 weeks
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: Queen's University Other

Overall Clinical Trial Officials and Contacts

Roumen V. Milev, MD Principal Investigator Queen's University  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00272025

Study ID Number: PSIY-207-05

ClinicalTrials.gov Identifier: NCT00272025

Health Authority: Canada: Health Canada

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