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Aripiprazole Augmentation of SSRI Therapy in Treatment Refractory Depression

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ClinicalTrials.gov Identifier: NCT00608543
Recruitment Status : Completed
First Posted : February 6, 2008
Results First Posted : October 26, 2012
Last Update Posted : October 26, 2012
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Prabha Sunderajan, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Intervention Drug: Aripiprazole
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open-label Aripiprazole Augmentation
Hide Arm/Group Description Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks
Period Title: Overall Study
Started 17
Completed 13
Not Completed 4
Reason Not Completed
Adverse Event             4
Arm/Group Title Open-label Aripiprazole Augmentation
Hide Arm/Group Description Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
48.18  (7.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
13
  76.5%
Male
4
  23.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants
17
1.Primary Outcome
Title Stockings of Cambridge (SOC) Mean Initial Thinking Time for 3-move Problems
Hide Description The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 3-move problems is the time (in milliseconds)taken to plan a problem solution for trials requiring 3 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment.
Time Frame baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention
Arm/Group Title Open Label Aripiprazole Augmentation
Hide Arm/Group Description:
This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: milliseconds
-4485.50  (6279.40)
2.Primary Outcome
Title Stockings of Cambridge (SOC) Mean Initial Thinking Time for 5-move Problems
Hide Description The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 5-move problems is the time (in milliseconds) taken to plan a problem solution for trials requiring 5 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment.
Time Frame baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention
Arm/Group Title Open Label Aripiprazole Augmentation
Hide Arm/Group Description:
This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: milliseconds
-4676.10  (8604.16)
3.Primary Outcome
Title Spatial Working Memory (SWM) Between Errors for 6-move Problems
Hide Description The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. Between errors are times the subject revisits a box in which a token was previously found; errors are calculated for 4-, 6-, and 8-box trials. Higher numbers indicate poorer performance. Errors reported are the difference between baseline and 6 weeks post-treatment.
Time Frame baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Completers because data were collected pre- and post-treatment
Arm/Group Title Spatial Working Memory Between Errors for 6-move Problems
Hide Arm/Group Description:
This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: number of errors
-4.00  (4.67)
4.Primary Outcome
Title Spatial Working Memory (SWM) Strategy Score
Hide Description The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. The Strategy score represents the number of times a participant begins a search with the same box for 6- and 8-box problems. Minimum score is 8 and maximum score is 56. Higher numbers indicate poorer performance. Score reported is the difference between baseline and 6 weeks post-treatment.
Time Frame baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention
Arm/Group Title Open Label Aripiprazole Augmentation
Hide Arm/Group Description:
This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.15  (4.52)
5.Secondary Outcome
Title Quality of Life Enjoyment and Satisfaction Questionnaire
Hide Description The Q-LES-Q general activities is designed to measure subjective satisfaction and enjoyment, as opposed to function, in various domains including physical health, feelings, work, household duties, school/course work, leisure time activities, social relations, and general activities. The raw score is converted into a percent of the maximum possible score and range from 0 to 100. Higher scores indicate greater enjoyment and satisfaction.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study completers who completed the Q-LES-Q pre- and post-intervention; mean represents mean difference from pre- to post-intervention
Arm/Group Title Open Label Aripiprazole Augmentation
Hide Arm/Group Description:
This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.81  (0.48)
6.Secondary Outcome
Title Change in Hamilton Rating Scale for Depression (HRSD - 17-item)
Hide Description The HRSD 17-item scale is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression. Scores range from 0 to 52, with higher scores indicating higher levels of depression severity.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study completers who completed the HRSD pre- and post-intervention; mean represents mean difference from pre- to post-intervention
Arm/Group Title Open Label Aripiprazole Augmentation
Hide Arm/Group Description:
This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
-11.42  (4.50)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open-label Aripiprazole Augmentation
Hide Arm/Group Description Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks
All-Cause Mortality
Open-label Aripiprazole Augmentation
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Open-label Aripiprazole Augmentation
Affected / at Risk (%)
Total   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open-label Aripiprazole Augmentation
Affected / at Risk (%)
Total   14/17 (82.35%) 
Cardiac disorders   
palpitations   2/17 (11.76%) 
dizziness on standing   3/17 (17.65%) 
chest pain   2/17 (11.76%) 
Ear and labyrinth disorders   
ringing in the ears   6/17 (35.29%) 
Eye disorders   
blurred vision   5/17 (29.41%) 
Gastrointestinal disorders   
diarrhea   8/17 (47.06%) 
constipation   8/17 (47.06%) 
dry mouth   6/17 (35.29%) 
nausea/vomiting   3/17 (17.65%) 
General disorders   
general malaise   8/17 (47.06%) 
fatigue   13/17 (76.47%) 
decreased energy   10/17 (58.82%) 
Nervous system disorders   
headache   14/17 (82.35%) 
tremors   4/17 (23.53%) 
poor coordination   6/17 (35.29%) 
dizziness   5/17 (29.41%) 
restlessness   12/17 (70.59%) 
difficulty sleeping   13/17 (76.47%) 
sleeping too much   9/17 (52.94%) 
anxiety   10/17 (58.82%) 
poor concentration   3/17 (17.65%) 
Renal and urinary disorders   
difficulty urinating   1/17 (5.88%) 
painful urination   1/17 (5.88%) 
frequent urination   6/17 (35.29%) 
Reproductive system and breast disorders   
menstrual irregularity   2/17 (11.76%) 
loss of sexual desire   11/17 (64.71%) 
trouble achieving orgasm   4/17 (23.53%) 
trouble with erections   1/17 (5.88%) 
Skin and subcutaneous tissue disorders   
rash   2/17 (11.76%) 
increased perspiration   6/17 (35.29%) 
itching   1/17 (5.88%) 
dry skin   1/17 (5.88%) 
Indicates events were collected by systematic assessment
Note that because this is an augmentation trial, reported AEs are due to combined treatment with escitalopram, citalopram, or sertraline AND aripiprazole.
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
Layout table for Results Point of Contact information
Name/Title: Dr.Prabha Sunderajan
Organization: UT Southwestern Medical Center
Phone: 214-648-0156
EMail: prabha.sunderajan@utsouthwestern.edu
Layout table for additonal information
Responsible Party: Prabha Sunderajan, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00608543     History of Changes
Other Study ID Numbers: 042004-011
First Submitted: January 23, 2008
First Posted: February 6, 2008
Results First Submitted: November 15, 2011
Results First Posted: October 26, 2012
Last Update Posted: October 26, 2012