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Trial record 29 of 33 for:    augmentation | "Depressive Disorder, Treatment-Resistant"

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
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Depressive Disorder, Major
Intervention Drug: Aripiprazole
Enrollment 15

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aripiprazole
Hide Arm/Group Description aripiprazole augmentation treatment
Period Title: Overall Study
Started 15
Completed 11
Not Completed 4
Reason Not Completed
Withdrawal by Subject             4
Arm/Group Title Aripiprazole
Hide Arm/Group Description aripiprazole augmentation treatment
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
  93.3%
>=65 years
1
   6.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
46  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
10
  66.7%
Male
5
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Hamilton Depression Rating Scale (HDRS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Adults with treatment resistant depression, all subjects with data after baseline (14 of 15 subjects).
Arm/Group Title Aripiprazole
Hide Arm/Group Description:
aripiprazole augmentation treatment
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: participants
7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole
Comments Null hypothesis would be no change in the HDRS score pre- to post- treatment with aripiprazole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method t-test, 2 sided
Comments df=13
Method of Estimation Estimation Parameter t statistic
Estimated Value 4.7
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Clinical Global Impressions Improvement Scale (CGI)
Hide Description clinician rated improvement, score on CGI scale ranging from 1 (very much improved) to 7 (very much worse)
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
all subjects for whom data was available after beginning aripiprazole augmentation (14 of 15 subjects)
Arm/Group Title Aripiprazole
Hide Arm/Group Description:
aripiprazole augmentation treatment for treatment resistant depression
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: units on CGI scale
2.8  (1.1)
3.Secondary Outcome
Title Change in Global Assessment of Functioning Scale (GAFS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects (14/15) for whom data was available after starting aripiprazole augmentation
Arm/Group Title Aripiprazole
Hide Arm/Group Description:
aripiprazole augmentation treatment
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: points on GAFS scale
7.3  (4.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole
Comments Null hypothesis would be no change in the GAFS score pre- to post- treatment with aripiprazole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .009
Comments [Not Specified]
Method t-test, 2 sided
Comments df=13
Method of Estimation Estimation Parameter t statistic
Estimated Value -3.1
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Beck Depression Inventory (BDI) Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants for whom data was available after starting aripiprazole augmentation
Arm/Group Title Aripiprazole
Hide Arm/Group Description:
aripiprazole augmentation treatment
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: points on BDI scale
4.2  (10.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole
Comments Null hypothesis would be no change in the BDI score pre- to post- treatment with aripiprazole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .008
Comments [Not Specified]
Method t-test, 2 sided
Comments df=13
Method of Estimation Estimation Parameter t statistic
Estimated Value 3.1
Estimation Comments [Not Specified]
Time Frame 16 weeks, during and after the clinical trial
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aripiprazole
Hide Arm/Group Description aripiprazole augmentation treatment
All-Cause Mortality
Aripiprazole
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aripiprazole
Affected / at Risk (%) # Events
Total   8/15 (53.33%)    
Gastrointestinal disorders   
nausea *  7/15 (46.67%)  15
Nervous system disorders   
fatigue *  8/15 (53.33%)  15
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: David Hellerstein MD
Organization: NY State Psychiatric Institute
Phone: 6467748000
Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00220636     History of Changes
Other Study ID Numbers: SLR-04-028
First Submitted: September 21, 2005
First Posted: September 22, 2005
Results First Submitted: April 15, 2009
Results First Posted: February 20, 2015
Last Update Posted: May 26, 2016