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