Clinical Trial: Treatment Resistant Bipolar Depression

This study is not yet open for patient recruitment.
Verified by Queen''''s University December 2005

Sponsored by: Queen''''s University
Information provided by: Queen''''s University
ClinicalTrials.gov Identifier: NCT00272025

Purpose

Adding Escitalopram to mood stablizer in patients with Bipolar Depression, not responding to mood stabilizer or atypical antipsychotic will improve their response in rates similar or better than adding a second M.S./AA.
Condition Intervention Phase
Bipolar Depression
 Drug: Escitalopram, Lomotrigine, Seroquel
Phase I

MedlinePlus related topics:  Bipolar Disorder

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study

Official Title: Twelve Week Double Blind Randomized Trial of Escitalopram Versus Mood Stablizer or Atypical Antipsychotic Augmentation of Mood Stabilizer or Atypical Atipsychotic for Treatment Resistant Bipolar Depression With One Year Open Label Extension

Further study details as provided by Queen''''s University:
Primary Outcomes: To evaluate improvement
Expected Total Enrollment:  40

Study start: February 2006;  Expected completion: January 2008
Last follow-up: January 2008;  Data entry closure: January 2008

The purpose of this study is to look at the effect, safety and tolerance to a drug called Escitalopram versus a mood stabilizer (MS) or atypical antipsychotic(AA) when it is added to your current MS or AA over a 12 week period of time.

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • You must be age 18 or older
  • You must have a diagnosis of Bipolar Disorder and currently be in depressive state, which has not responded to your present mood stabilizer or atypical antipsychotic alone or combined with an antidepressant medication.

Exclusion Criteria:

  • You are pregnant or breastfeeding
  • You have a history of seizure disorder or other unstable medical condition
  • You have received Electroconvulsive Therapy or Transcranial Magnetic Stimulation in the last three months
  • You have experienced hallucinations or delusions

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00272025

Roumen V Milev, MD      613-548-5567  Ext. 5711    milevr@pccchealth.org
Ingela Marlin, RN      613-548-5567  Ext. 6123    marlini@pccchealth.org

Study chairs or principal investigators

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

More Information

Study ID Numbers:  PSIY-207-05
Last Updated:  January 3, 2006
Record first received:  January 3, 2006
ClinicalTrials.gov Identifier:  NCT00272025
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2006-01-10



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