Treatment Resistant Bipolar Depression - Tabular View

Tracking Information

First Received Date ^ICMJE

January 3, 2006

Last Updated Date

September 23, 2009

Start Date ^ICMJE

October 2006

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To evaluate the response rates when Escitalopram vs. placeboes added to the current mood stabilizer or antipsychotic medication [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To evaluate improvement

Change History

Complete list of historical versions of study NCT00272025 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate efficacy, safety and tolerability of added Escitalopram, to a mood stabilizer or atypical antipsychotic. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Descriptive Information

Brief Title ^ICMJE

Treatment Resistant Bipolar Depression

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Bipolar Depression

Intervention ^ICMJE

Drug: Escitalopram
Drug: placebo

Study Arms / Comparison Groups

Active Comparator: 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)

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Estimated Completion Date

January 2010

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00272025

Responsible Party

Roumen, Milev, Providence Care, Mental Health Services

Study ID Numbers ^ICMJE

PSIY-207-05

Study Sponsor ^ICMJE

Queen's University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Roumen V. Milev, MD

Queen's University

Information Provided By

Queen's University

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP