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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

Page last updated: November 03, 2008

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