Treatment Resistant Bipolar Depression

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Primary Purpose

Status

Terminated

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Escitalopram

placebo

About this trial

This is an interventional treatment trial for Bipolar Depression focused on measuring Bipolar Depression, Escitalopram, Mood Stabilizer, Atypical Antipsychotic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Providence Care, Mental Health Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm 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)

to be filled in

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00272025

First Posted

January 3, 2006

Last Updated

December 14, 2015

Sponsor

Queen's University

1. Study Identification

Unique Protocol Identification Number

NCT00272025

Brief Title

Treatment Resistant Bipolar Depression

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Terminated

Why Stopped

Lundbeck withdrew committment - expiring patents and prolonged inactivity

Study Start Date

October 2006 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Queen's University

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Depression

Keywords

Bipolar Depression, Escitalopram, Mood Stabilizer, Atypical Antipsychotic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Active Comparator

Arm 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)

Arm Title

2

Arm Type

Placebo Comparator

Arm Description

to be filled in

Intervention Type

Drug

Intervention Name(s)

Escitalopram

Other Intervention Name(s)

Cipralex

Intervention Description

10mg to 20mg tablet daily for 6 weeks

Intervention Type

Drug

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

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

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roumen V. Milev, MD

Organizational Affiliation

Queen's University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Providence Care, Mental Health Services

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 4X3

Country

Canada

Bipolar Depression

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial