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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Efficacy Study

Study Primary Completion Date: January 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Escitalopram
  • 10mg to 20mg tablet daily for 12 weeks with optional one year extension
• Drug: Seroquel or Lamotrigine
  • Seroquel 100mg to 600mg orally daily for 12 weeks in divided dose OR Lamotrigine 50mg to 200mg orally daily as one dose

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • There is a 50% chance of being randomized to Escitalopram in addition to current atypical antipsychotic (minimum dose risperidone 3mg, olanzapine 10mg or seroquel 400mg) or mood stabilizer (lithium, epival or lamotrigine)
• Active Comparator: 2
  • those entering the study on an atypical antipsychotic (minimum dose risperidone 3mg, olanzapine 10mg or seroquel 400mg) have a 50% chance of being randomized to lamotrigine those entering the study on a mood stabilizer (lithium, epival, lamotrigine) have a 50% chance of being randomized to seroquel

Primary Measures

• To evaluate the response rates when Escitalopram vs. seroquel or lamotrigine is added to the current mood stabilizer or antipsychotic medication
  • Time Frame: 12 weeks with optional one year extension
    Safety Issue?: No

Secondary Measures

• To evaluate efficacy, safety and tolerability of added Escitalopram, Lamotrigine or Seroquel to a mood stabilizer or atypical antipsychotic.
  • Time Frame: 12 weeks with one year optional extension
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Queen's University

Overall Clinical Trial Officials and Contacts

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

Overall Contact: Roumen V Milev, MD (613) 548-5567 milevr@pccchealth.org

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00272025

Study ID Number: PSIY-207-05

ClinicalTrials.gov Identifier: NCT00272025

Health Authority: Canada: Health Canada