Treatment Resistant Bipolar Depression - Full Text View

Sponsored by:	Queen's University
Information provided by:	Queen's University
ClinicalTrials.gov Identifier:	NCT00272025

Purpose

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.

Condition	Intervention	Phase
Bipolar Depression	Drug: Escitalopram Drug: Seroquel or Lamotrigine	Phase I

MedlinePlus related topics: Depression

Drug Information available for: Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Quetiapine Quetiapine fumarate Lamotrigine

U.S. FDA Resources

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

Further study details as provided by Queen's University:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	October 2006
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: 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)	Drug: Escitalopram 10mg to 20mg tablet daily for 12 weeks with optional one year extension
2: Active Comparator 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	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

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272025

Contacts

Contact: Roumen V Milev, MD	(613) 548-5567 ext 5711	milevr@pccchealth.org
Contact: Teresa Garrah, RN	(613) 548-5567 ext 5717	garraht1@providencecare.ca

Locations

Canada, Ontario
Providence Care, Mental Health Services	Recruiting
Kingston, Ontario, Canada, K7L 4X3
Contact: Teresa Garrah, RN (613) 546-1101 ext 5717 garraht1@providencecare.ca
Principal Investigator: Dr. R Milev

Sponsors and Collaborators

Queen's University

Investigators

Principal Investigator:

Roumen V. Milev, MD

Queen's University

More Information

Responsible Party:	Providence Care, Mental Health Services ( Roumen, Milev )
Study ID Numbers:	PSIY-207-05
Study First Received:	January 3, 2006
Last Updated:	August 12, 2008
ClinicalTrials.gov Identifier:	NCT00272025
Health Authority:	Canada: Health Canada

Keywords provided by Queen's University:

Bipolar Depression
Escitalopram
Lamotrigine

Seroquel
Mood Stabilizer
Atypical Antipsychotic

Study placed in the following topic categories:

Depression
Bipolar Disorder
Depressive Disorder
Citalopram
Serotonin
Behavioral Symptoms
Calcium, Dietary

Affective Disorders, Psychotic
Quetiapine
Mental Disorders
Mood Disorders
Lamotrigine
Psychotic Disorders
Dexetimide

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Calcium Channel Blockers
Antiparkinson Agents
Cholinergic Agents
Membrane Transport Modulators
Therapeutic Uses
Antidepressive Agents, Second-Generation

Antidepressive Agents
Tranquilizing Agents
Central Nervous System Depressants
Cardiovascular Agents
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009