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Dopaminergic Effects of Adjunctive Aripiprazole on the Brain in Treatment-Resistant Depression

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ClinicalTrials.gov Identifier: NCT00953745
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : April 19, 2018
Last Update Posted : April 19, 2018
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Other
Condition: Major Depressive Disorder
Interventions: Drug: Escitalopram
Drug: Aripiprazole
Drug: Placebo Capsule
Drug: Placebo Tablet

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Depressed Participants

Subjects with treatment-resistant depression (TRD) will receive escitalopram combined with an adjunctive placebo capsule for 8 weeks.

Subjects who fail to respond will continue to receive escitalopram and additionally change to receive a placebo tablet resembling the active augmentation agent Aripiprazole (ARP) for 2 weeks.

Control Participants Non-depressed, age- and sex-matched subjects without a DSM-IV Axis I diagnosis will serve as controls. They will not receive antidepressant, ARP, or any drug augmentation and will be used to compare the pre-ARP and post-ARP treatment brain images to draw conclusions about the pre-treatment state (depression) and post-treatment state (depression responders).

Participant Flow for 3 periods

Period 1:   Phase 1: 8 Weeks Escitalopram + Placebo
    Depressed Participants   Control Participants
STARTED   37   6 
COMPLETED   24   6 
NOT COMPLETED   13   0 
Pregnancy                1                0 
Withdrawal by Subject                2                0 
Lost to Follow-up                3                0 
Adverse Event                1                0 
Screen failures                6                0 

Period 2:   Phase 2: 2 Weeks Escitalopram + Placebo
    Depressed Participants   Control Participants
STARTED   18   0 
COMPLETED   17   0 
NOT COMPLETED   1   0 
Pregnancy                1                0 

Period 3:   ARP Phase: 6 Weeks Escitalopram + ARP
    Depressed Participants   Control Participants
STARTED   17   0 
COMPLETED   17   0 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Depressed Participants

Subjects with treatment-resistant depression (TRD) will receive escitalopram combined with an adjunctive placebo capsule for 8 weeks.

Subjects who fail to respond will continue to receive escitalopram and additionally change to receive a placebo tablet resembling the active augmentation agent Aripiprazole (ARP) for 2 weeks.

Subjects who fail to respond to escitalopram after the 2 phase placebo treatment will enter the ARP augmentation phase of the study and will receive escitalopram augmentation with ARP.

Subjects will have 3 neuroimaging scans: F-DOPA PET, raclopride PET, and functional MRI conducted after 10 weeks of treatment and repeated after 6 weeks of ARP treatment.

Control Participants Non-depressed, age- and sex-matched subjects without a DSM-IV Axis I diagnosis will serve as controls. They will not receive antidepressant, ARP, or any drug augmentation and will be used to compare the pre-ARP and post-ARP treatment brain images to draw conclusions about the pre-treatment state (depression) and post-treatment state (depression responders).
Total Total of all reporting groups

Baseline Measures
   Depressed Participants   Control Participants   Total 
Overall Participants Analyzed 
[Units: Participants]
 37   6   43 
Age 
[Units: Years]
Mean (Full Range)
 41.69 
 (19 to 54) 
 45.67 
 (31 to 54) 
 42.27 
 (19 to 54) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      27  73.0%      5  83.3%      32  74.4% 
Male      10  27.0%      1  16.7%      11  25.6% 
Region of Enrollment 
[Units: Participants]
     
United States   37   6   43 


  Outcome Measures

1.  Primary:   Fluorodopa Uptake Values in Brain Images of Aripiprazole Augmentation Responders   [ Time Frame: Week 10 and Week 16 (6 weeks of combined therapy) ]

2.  Secondary:   Depression Symptom Change on The Montgomery–Åsberg Depression Rating (MADRS) Scale Between ARP Responders and Non-responders.   [ Time Frame: Week 10 and Week 16 (6 weeks of combined therapy) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Charles R. Conway, MD
Organization: Washington University School of Medicine
phone: 314-362-7566
e-mail: conwayc@psychiatry.wustl.edu



Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00953745     History of Changes
Other Study ID Numbers: 201101790-2
First Submitted: August 4, 2009
First Posted: August 6, 2009
Results First Submitted: January 20, 2016
Results First Posted: April 19, 2018
Last Update Posted: April 19, 2018