Abilify as an Adjunctive Treatment for Refractory Depression
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ClinicalTrials.gov Identifier: NCT00220636 |
Recruitment Status :
Completed
First Posted : September 22, 2005
Results First Posted : February 20, 2015
Last Update Posted : May 26, 2016
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Sponsor:
St. Luke's-Roosevelt Hospital Center
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
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Tracking Information | ||||
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First Submitted Date ICMJE | September 21, 2005 | |||
First Posted Date ICMJE | September 22, 2005 | |||
Results First Submitted Date ICMJE | April 15, 2009 | |||
Results First Posted Date ICMJE | February 20, 2015 | |||
Last Update Posted Date | May 26, 2016 | |||
Study Start Date ICMJE | March 2005 | |||
Actual Primary Completion Date | March 2007 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Hamilton Depression Rating Scale (HDRS) [ Time Frame: 12 weeks ] 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.
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Original Primary Outcome Measures ICMJE |
Hamilton Depression Rating Scale (HDRS) | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Abilify as an Adjunctive Treatment for Refractory Depression | |||
Official Title ICMJE | Abilify (Aripiprazole) as an Adjunctive Treatment for Refractory Unipolar Depression | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Depressive Disorder, Major | |||
Intervention ICMJE | Drug: Aripiprazole
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.
Other Name: Abilify
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Study Arms ICMJE | Experimental: Aripiprazole
Aripiprazole 5 to 30 mg/day
Intervention: Drug: Aripiprazole
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Publications * | Hellerstein DJ. Aripiprazole as an adjunctive treatment for refractory major depression. Prog Neuropsychopharmacol Biol Psychiatry. 2004 Dec;28(8):1347-8. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
15 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | January 2008 | |||
Actual Primary Completion Date | March 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00220636 | |||
Other Study ID Numbers ICMJE | SLR-04-028 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | St. Luke's-Roosevelt Hospital Center | |||
Study Sponsor ICMJE | St. Luke's-Roosevelt Hospital Center | |||
Collaborators ICMJE | Bristol-Myers Squibb | |||
Investigators ICMJE |
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PRS Account | St. Luke's-Roosevelt Hospital Center | |||
Verification Date | October 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |