Treatment Resistant Bipolar Depression

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ClinicalTrials.gov Identifier: NCT00272025

Recruitment Status : Terminated (Lundbeck withdrew committment - expiring patents and prolonged inactivity)

First Posted : January 4, 2006

Last Update Posted : December 16, 2015

Sponsor:

Information provided by (Responsible Party):

Dr. Roumen Milev, Queen's University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Bipolar Depression	Drug: Escitalopram Drug: placebo	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Six Week Double Blind, Randomized Trial of Escitalopram Add On for Treatment Resistant Bipolar Depression
Study Start Date :	October 2006
Actual Primary Completion Date :	January 2010
Actual Study Completion Date :	January 2010

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Depression

Drug Information available for: Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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)	Drug: Escitalopram 10mg to 20mg tablet daily for 6 weeks Other Name: Cipralex
Placebo Comparator: 2 to be filled in	Drug: placebo

Outcome Measures

Primary Outcome Measures :

To evaluate the response rates when Escitalopram vs. placeboes added to the current mood stabilizer or antipsychotic medication [ Time Frame: 6 weeks ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00272025

Locations

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Canada, Ontario
Providence Care, Mental Health Services
Kingston, Ontario, Canada, K7L 4X3

Sponsors and Collaborators

Queen's University

Investigators

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

More Information

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Responsible Party:	Dr. Roumen Milev, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier:	NCT00272025 History of Changes
Other Study ID Numbers:	PSIY-207-05
First Posted:	January 4, 2006 Key Record Dates
Last Update Posted:	December 16, 2015
Last Verified:	December 2015

Keywords provided by Dr. Roumen Milev, Queen's University:


Bipolar Depression Escitalopram Mood Stabilizer Atypical Antipsychotic

Additional relevant MeSH terms:

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Dexetimide Citalopram Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Antiparkinson Agents Anti-Dyskinesia Agents Autonomic Agents Peripheral Nervous System Agents Cholinergic Agents Depression	Depressive Disorder Bipolar Disorder Behavioral Symptoms Mood Disorders Mental Disorders Bipolar and Related Disorders Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Parasympatholytics Muscarinic Antagonists Cholinergic Antagonists

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