Treatment Resistant Bipolar Depression

Bipolar Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00272025
• Other study ID #: PSIY-207-05
• Status: Terminated
• Phase: Phase 1
• First received: January 3, 2006
• Last updated: December 14, 2015
• Start date: October 2006
• Est. completion date: January 2010

Study information

• Verified date: December 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Drug:
• Escitalopram
10mg to 20mg tablet daily for 6 weeks
• placebo

Locations

Country	Name	City	State
Canada	Providence Care, Mental Health Services	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the response rates when Escitalopram vs. placeboes added to the current mood stabilizer or antipsychotic medication		6 weeks	No
Secondary	To evaluate efficacy, safety and tolerability of added Escitalopram, to a mood stabilizer or atypical antipsychotic.		6 weeks	Yes