Treatment Resistant Bipolar Depression

NCT00272025 | Terminated Phase 1

• 1 other identifier: PSIY-207-05
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Depression

Keywords

Bipolar Depression; Escitalopram; Mood Stabilizer; Atypical Antipsychotic

Outcome Measures

Primary Outcomes (1)

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

  6 weeks

Secondary Outcomes (1)

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

  6 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

PLACEBO COMPARATOR

to be filled in

Drug: placebo

Interventions

Escitalopram DRUG

10mg to 20mg tablet daily for 6 weeks

Also known as: Cipralex

1

placebo DRUG

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Providence Care, Mental Health Services

Kingston, Ontario, K7L 4X3, Canada

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Escitalopram; Dexetimide

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Roumen V. Milev, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 3, 2006
• First Posted: January 4, 2006
• Study Start: October 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

CA (1)