Status:
COMPLETED
Dopaminergic Effects of Adjunctive Aripiprazole on the Brain in Treatment-Resistant Depression
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
Aripiprazole has been approved by the FDA for augmenting ineffective/partially effective oral antidepressant therapy in patients suffering from major depression. The mechanism by which this augmentati...
Detailed Description
This study is designed to help understand the mechanism of action of ARP in major depressive disorder (MDD) augmentation. Subjects will undergo exposure to an existing antidepressant (Lexapro 10-20mg)...
Eligibility Criteria
Inclusion
- Treatment Group
- Subjects with known history of MDD verified using the Mini International Neuropsychiatric Interview and a Hamilton Depression Rating Scale 17-item score of at least 18
- Subjects must have failed to respond to one previous adequate dose-duration trial of antidepressant therapy
- Must complete the MRI screening tool and demonstrate ability to receive an MRI
- For entry into the ARP augmentation phase the subject must be a non-responder to the escitalopram phase as demonstrated by a MADRS score at week 10, that is not reduced by greater than 50% from baseline.
Exclusion
- Subjects cannot be smokers
- No significant history of anxiety disorder
- Cannot be pregnant or lactating and sexually active women of childbearing potential must use a medically accepted means of contraception
- The following DSM-IV diagnoses are excluded: Organic mental disorder; substance abuse/dependence, including alcohol, active within the last year; schizophrenia, paranoid or delusional disorders; other psychotic disorders; panic disorder; generalized anxiety disorder; obsessive-compulsive disorder, or post-traumatic stress disorder; bipolar disorder; bulimia nervosa; anorexia nervosa
- Subjects with serious suicidal risks
- Subjects who have taken any antidepressant medication other than escitalopram within 5 half lives, of the most recent antidepressant taken
- Subjects involved in any other form of treatment for depression
- Subjects who have demonstrated any previous inadequate antidepressant response to electroconvulsive therapy (ECT)
- Subjects who have received ECT for the current depression episode
- Subjects who have been hospitalized within 4 weeks of the study
- Subjects who have received treatment with a monoaminoxidase inhibitor within 2 weeks of enrollment
- Subjects with a known allergy, hypersensitivity, or previous unresponsiveness to aripiprazole or known intolerance to any study medications
- Subjects with a history of participation in any investigational medication trial in the past month
- A positive drug screen or substance use disorder in the past 12 months
- History of any thyroid pathology
- History of serotonin syndrome or neuroleptic malignant syndrome
- History of seizure disorder
- Subjects who have participated in a trial using PET scans in the past 12 months and in any trial in the past 30 days.
- Control Group
- Inclusion Criteria:
- Ages 18-55 matched to a study subject
- Must be a healthy subject with no significant medical history
- Must complete the MRI screening tool and demonstrate ability to receive an MRI
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00953745
Start Date
May 1 2009
End Date
December 1 2012
Last Update
April 19 2018
Active Locations (1)
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1
Washington University in St. Louis, School of Medicine
St Louis, Missouri, United States, 63110