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Abilify as an Adjunctive Treatment for Refractory Depression

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
St. Luke's-Roosevelt Hospital Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Major Depression, Depression, Unipolar Depression, Treatment Resistant Depression, Adjunctive treatment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female outpatients between the ages of 18 and 70. Patients with a principal Diagnostic and Statistical Manual fourth edition (DSM-IV) diagnosis of Major Depressive Disorder, unipolar, nonpsychotic type Patients with a total of 14 or higher on the 17-item Hamilton Depression Scale at baseline Patients who have had treatment with an SSRI at an adequate dose (see Table for a minimum of 6 weeks (i.e. 6 wks at the dose defined as adequate in Table 2) Patients who agree to use acceptable method of birth control throughout the study Exclusion Criteria: Patients with any of the following DSM-IV diagnoses: Delirium, Dementia, Amnestic, or other Cognitive Disorders. Bipolar Disorder or cyclothymia, Schizophrenia, Delusional (Paranoid) Disorders and Psychotic Disorders not elsewhere classified, Severe Borderline Personality Disorder, Anorexia Nervosa, or Bulimia. Patients who, within the past 6 months, met DSM-IV criteria for abuse of or dependence on any drug, including alcohol. Patients who are pregnant or nursing women. Patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following: (a) report of having a specific plan for killing themselves, (b) a score of 3 or higher on the Hamilton Depression Rating Scale item #3 as rated by the treating clinician at Week 0, or (c) a suicide attempt within the last 6 months which required medical attention, such as an emergency room visit or which is considered by the treating physician to have been possibly life threatening Patients with unstable medical conditions such as untreated or uncontrolled hyperthyroidism, hypothyroidism, hypertension (defined as blood pressure>150/90), cardiovascular disease, diabetes, HIV (by report of patient). Patients with a history of seizures.

Sites / Locations

  • Depression Evaluation Service, NY State Psychiatric Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aripiprazole

Arm Description

Aripiprazole 5 to 30 mg/day

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale (HDRS)
Clinician rated measure of depression, mean score; this study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7) Outcome is the number of these subjects whose depression "responded" after treatment with aripiprazole, which means a 50% or greater decrease in Hamilton Depression Rating Scale scores at week 12.

Secondary Outcome Measures

Clinical Global Impressions Improvement Scale (CGI)
clinician rated improvement, score on CGI scale ranging from 1 (very much improved) to 7 (very much worse)
Change in Global Assessment of Functioning Scale (GAFS)
Ranging from 0 to 100, with higher score indicating better global functioning. Outcome is the post-treatment GAFS score compared to the pre-treatment GAFS score.
Change in Beck Depression Inventory (BDI) Score
21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression. Outcome is the subject's total BDI score post-treatment compared to the subject's total BDI score pre-treatment.

Full Information

First Posted
September 21, 2005
Last Updated
April 26, 2016
Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00220636
Brief Title
Abilify as an Adjunctive Treatment for Refractory Depression
Official Title
Abilify (Aripiprazole) as an Adjunctive Treatment for Refractory Unipolar Depression
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a study of the effectiveness of adding Abilify (aripiprazole), an atypical antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI) antidepressant treatment for depressed outpatients who are not responding fully to SSRI treatment alone. It is hypothesized that patients' functioning will improve after 12 weeks of treatment with Aripiprazole and SSRI medication.
Detailed Description
This is a pilot study of the effectiveness of adding Abilify (aripiprazole), an atypical antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI) antidepressant treatment for depressed outpatients who are not responding fully to SSRI treatment alone. Fifteen subjects will be given aripiprazole in a flexible dosing schedule and followed for 12 weeks, while continuing their ongoing SSRI medication. Assessments of depressive symptoms, overall functioning, social functioning, and side effects will be completed. It is hypothesized that patients' functioning will improve after 12 weeks of treatment with Aripiprazole and SSRI medication.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Major Depression, Depression, Unipolar Depression, Treatment Resistant Depression, Adjunctive treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aripiprazole
Arm Type
Experimental
Arm Description
Aripiprazole 5 to 30 mg/day
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Aripiprazole dose ranging from 5 to 30 mg/day, augmenting antidepressant treatment. Aripiprazole is used as an augmenting medication on an open label basis for patients on antidepressant medication who continue to have depressive symptoms. This is an open label case series in which all subjects receive aripiprazole augmentation. There is no comparator group.
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (HDRS)
Description
Clinician rated measure of depression, mean score; this study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7) Outcome is the number of these subjects whose depression "responded" after treatment with aripiprazole, which means a 50% or greater decrease in Hamilton Depression Rating Scale scores at week 12.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Clinical Global Impressions Improvement Scale (CGI)
Description
clinician rated improvement, score on CGI scale ranging from 1 (very much improved) to 7 (very much worse)
Time Frame
12 weeks
Title
Change in Global Assessment of Functioning Scale (GAFS)
Description
Ranging from 0 to 100, with higher score indicating better global functioning. Outcome is the post-treatment GAFS score compared to the pre-treatment GAFS score.
Time Frame
baseline and 12 weeks
Title
Change in Beck Depression Inventory (BDI) Score
Description
21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression. Outcome is the subject's total BDI score post-treatment compared to the subject's total BDI score pre-treatment.
Time Frame
baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female outpatients between the ages of 18 and 70. Patients with a principal Diagnostic and Statistical Manual fourth edition (DSM-IV) diagnosis of Major Depressive Disorder, unipolar, nonpsychotic type Patients with a total of 14 or higher on the 17-item Hamilton Depression Scale at baseline Patients who have had treatment with an SSRI at an adequate dose (see Table for a minimum of 6 weeks (i.e. 6 wks at the dose defined as adequate in Table 2) Patients who agree to use acceptable method of birth control throughout the study Exclusion Criteria: Patients with any of the following DSM-IV diagnoses: Delirium, Dementia, Amnestic, or other Cognitive Disorders. Bipolar Disorder or cyclothymia, Schizophrenia, Delusional (Paranoid) Disorders and Psychotic Disorders not elsewhere classified, Severe Borderline Personality Disorder, Anorexia Nervosa, or Bulimia. Patients who, within the past 6 months, met DSM-IV criteria for abuse of or dependence on any drug, including alcohol. Patients who are pregnant or nursing women. Patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following: (a) report of having a specific plan for killing themselves, (b) a score of 3 or higher on the Hamilton Depression Rating Scale item #3 as rated by the treating clinician at Week 0, or (c) a suicide attempt within the last 6 months which required medical attention, such as an emergency room visit or which is considered by the treating physician to have been possibly life threatening Patients with unstable medical conditions such as untreated or uncontrolled hyperthyroidism, hypothyroidism, hypertension (defined as blood pressure>150/90), cardiovascular disease, diabetes, HIV (by report of patient). Patients with a history of seizures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J. Hellerstein, MD
Organizational Affiliation
NY State Psychiatric Institute, and St. Luke's - Roosevelt Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Depression Evaluation Service, NY State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15588762
Citation
Hellerstein DJ. Aripiprazole as an adjunctive treatment for refractory major depression. Prog Neuropsychopharmacol Biol Psychiatry. 2004 Dec;28(8):1347-8. doi: 10.1016/j.pnpbp.2004.06.016. No abstract available.
Results Reference
background
Links:
URL
http://www.DepressionNY.com
Description
Web Site for the Mood Disorders Research Program, with information about the study and the process of getting involved in research in general and specifically at our site

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Abilify as an Adjunctive Treatment for Refractory Depression

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