Treatment Resistant Bipolar Depression
Information source: Queen's University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Depression
Intervention: Escitalopram (Drug); Seroquel or Lamotrigine (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Queen's University Official(s) and/or principal investigator(s):
Roumen V. Milev, MD, Principal Investigator, Affiliation: Queen's University
Overall contact:
Roumen V Milev, MD, Phone: (613) 548-5567, Ext: 5711, Email: milevr@pccchealth.org
Summary
Adding Escitalopram to mood stabilizer (MS) in patients with Bipolar Depression, not
responding to mood stabilizer or atypical antipsychotic (AA) will improve their response in
rates similar or better than adding a second M. S./AA.
Clinical Details
Official title: Twelve Week Double Blind Randomized Trial of Escitalopram Versus Mood Stabilizer or Atypical Antipsychotic Augmentation of Mood Stabilizer or Atypical Antipsychotic for Treatment Resistant Bipolar Depression
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Efficacy Study
Primary outcome: To evaluate the response rates when Escitalopram vs. seroquel or lamotrigine is added to the current mood stabilizer or antipsychotic medication
Secondary outcome: To evaluate efficacy, safety and tolerability of added Escitalopram, Lamotrigine or Seroquel to a mood stabilizer or atypical antipsychotic.
Detailed description:
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
a patient's current MS or AA over a 12 week period of time.
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
Roumen V Milev, MD, Phone: (613) 548-5567, Ext: 5711, Email: milevr@pccchealth.org
Providence Care, Mental Health Services, Kingston, Ontario K7L 4X3, Canada; Recruiting
Teresa Garrah, RN, Phone: (613) 546-1101, Ext: 5717, Email: garraht1@providencecare.ca
Dr. R Milev, Principal Investigator
Additional Information
Starting date: October 2006
Ending date: January 2009
Last updated: August 12, 2008
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