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Treatment Resistant Bipolar Depression

Six Week Double Blind, Randomized Trial of Escitalopram Add On for Treatment Resistant Bipolar Depression

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00272025
Enrollment
1
Registered
2006-01-04
Start date
2006-10-31
Completion date
2010-01-31
Last updated
2015-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Depression

Keywords

Bipolar Depression, Escitalopram, Mood Stabilizer, Atypical Antipsychotic

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.

Interventions

DRUGEscitalopram

10mg to 20mg tablet daily for 6 weeks

DRUGplacebo

Sponsors

Queen's University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
To evaluate the response rates when Escitalopram vs. placeboes added to the current mood stabilizer or antipsychotic medication6 weeks

Secondary

MeasureTime frame
To evaluate efficacy, safety and tolerability of added Escitalopram, to a mood stabilizer or atypical antipsychotic.6 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026