MedPath

Treatment Resistant Bipolar Depression

Phase 1
Terminated
Conditions
Bipolar Depression
Interventions
Drug: placebo
Registration Number
NCT00272025
Lead Sponsor
Queen's University
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

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
1
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1EscitalopramThere 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)
2placeboto be filled in
Primary Outcome Measures
NameTimeMethod
To evaluate the response rates when Escitalopram vs. placeboes added to the current mood stabilizer or antipsychotic medication6 weeks
Secondary Outcome Measures
NameTimeMethod
To evaluate efficacy, safety and tolerability of added Escitalopram, to a mood stabilizer or atypical antipsychotic.6 weeks

Trial Locations

Locations (1)

Providence Care, Mental Health Services

🇨🇦

Kingston, Ontario, Canada

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