Treatment Resistant Bipolar Depression

Queen's University

Status and phase: Terminated; Phase 1

Conditions: Bipolar Depression

Treatments: Drug: placebo; Drug: Escitalopram

Study type: Interventional

Funder types: Other

Identifiers

NCT00272025

PSIY-207-05

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

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)

Treatment:

Drug: Escitalopram

2

Placebo Comparator group

Description:

to be filled in

Treatment:

Drug: placebo