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

Completed · Not applicable · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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 augmentation is achieved is not known. This study has been designed to test the hypothesis that the primary mechanism of action of aripiprazole (ARP) antidepressant augmentation is through the dopaminergic pathway. Two positron emission tomography (PET) scan procedures and a functional magnetic resonance imaging (fMRI) scan will be used to test this hypothesis.

Key facts

Study ID

NCT00953745

Run by

Washington University School of Medicine

People needed

43

Starts

2009-05-01

Expected to finish

2012-12-01

Last updated by the study team

2018-04-19

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• Exclusion Criteria:
• Cannot be a smoker

Where it is running

• Washington University in St. Louis, School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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