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Treatment Resistant Bipolar Depression

This study has been terminated.
(Lundbeck withdrew committment - expiring patents and prolonged inactivity)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00272025
First Posted: January 4, 2006
Last Update Posted: December 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Roumen Milev, Queen's University
  Purpose
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 Intervention Phase
Bipolar Depression Drug: Escitalopram Drug: placebo Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dr. Roumen Milev, Queen's University:

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 ]

Enrollment: 1
Study Start Date: October 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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
Canada, Ontario
Providence Care, Mental Health Services
Kingston, Ontario, Canada, K7L 4X3
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Roumen V. Milev, MD Queen's University
  More Information

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 Submitted: January 3, 2006
First Posted: January 4, 2006
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:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents