Abilify as an Adjunctive Treatment for Refractory Depression
|ClinicalTrials.gov Identifier: NCT00220636|
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : February 20, 2015
Last Update Posted : May 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder, Major||Drug: Aripiprazole||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Abilify (Aripiprazole) as an Adjunctive Treatment for Refractory Unipolar Depression|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||January 2008|
Aripiprazole 5 to 30 mg/day
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
- 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.
- Clinical Global Impressions Improvement Scale (CGI) [ Time Frame: 12 weeks ]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) [ Time Frame: baseline and 12 weeks ]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 [ Time Frame: baseline and 12 weeks ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220636
|United States, New York|
|Depression Evaluation Service, NY State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||David J. Hellerstein, MD||NY State Psychiatric Institute, and St. Luke's - Roosevelt Hospital Center|