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Treatment Resistant Bipolar Depression

Information source: Queen's University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Depression

Intervention: Escitalopram (Drug); placebo (Drug)

Phase: Phase 1

Status: Terminated

Sponsored by: Queen's University

Official(s) and/or principal investigator(s):
Roumen V. Milev, MD, Principal Investigator, Affiliation: Queen's University


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.

Clinical Details

Official title: Six Week Double Blind, Randomized Trial of Escitalopram Add On for Treatment Resistant Bipolar Depression

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: To evaluate the response rates when Escitalopram vs. placeboes added to the current mood stabilizer or antipsychotic medication

Secondary outcome: To evaluate efficacy, safety and tolerability of added Escitalopram, to a mood stabilizer or atypical antipsychotic.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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

Locations and Contacts

Providence Care, Mental Health Services, Kingston, Ontario K7L 4X3, Canada
Additional Information

Starting date: October 2006
Last updated: March 10, 2015

Page last updated: August 23, 2015

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