Treatment Resistant Bipolar Depression

Phase 1TerminatedNCT00272025

Queen's University1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bipolar Depression

Interventions

EscitalopramDRUG

10mg to 20mg tablet daily for 6 weeks

placeboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Providence Care, Mental Health Services

Kingston, Ontario, Canada

Outcomes

Primary Outcomes

To evaluate the response rates when Escitalopram vs. placeboes added to the current mood stabilizer or antipsychotic medication

Time frame: 6 weeks

Secondary Outcomes

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

Time frame: 6 weeks

Data from ClinicalTrials.gov

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