Treatment Resistant Bipolar Depression

This study has been terminated.
(Lundbeck withdrew committment - expiring patents and prolonged inactivity)
Sponsor:
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00272025
First received: January 3, 2006
Last updated: September 23, 2009
Last verified: September 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1
Study Start Date: October 2006
Estimated Study Completion Date: January 2010
Estimated 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 Drug: placebo

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Roumen, Milev, Providence Care, Mental Health Services
ClinicalTrials.gov Identifier: NCT00272025     History of Changes
Other Study ID Numbers: PSIY-207-05
Study First Received: January 3, 2006
Last Updated: September 23, 2009
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
Bipolar Depression
Escitalopram
Mood Stabilizer
Atypical Antipsychotic

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Dexetimide
Citalopram
Antipsychotic Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on July 29, 2014