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Neuroimaging Of Treatment Effects in Treatment-Resistant Depression

Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: escitalopram and adjunctive aripiprazole and placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Washington University School of Medicine

Official(s) and/or principal investigator(s):
Charles R Conway, MD, Principal Investigator, Affiliation: Washington University in St. Louis, School of Medicine

Overall contact:
Martha E Cornell, BSN, Phone: 314-362-0038, Email: cornellm@wustl.edu

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

Clinical Details

Official title: Dopaminergic Effects of Adjunctive Aripiprazole on the Brain in Treatment-Resistant Depression: A Raclopride/F-DOPA Positron Emission Tomography and Functional MRI Study.

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Use of PET and fMRI to demonstrate the differential pattern of dopaminergic activity, dopamine receptor binding in the putamen and caudate and correlation these findings to MADRS in MDD subjects treated with escitalopram and aripiprazole.

Secondary outcome: Correlation of D2binding before and after adjunctive aripiprazole with emergence of extrapyramidal symptoms and akathisia.

Detailed description: This is an eighteen week study including a two week taper off period. Forty five subjects will be started on 10mg escitalopram then titered to 20mg plus placebo. After 10 weeks of treatment, those subjects who do not respond to the escitalopram, as defined by a 50% reduction in their MADRS score, will be started on adjunctive aripiprazole at 2mg, titered to 10mg. Subjects will remain on the both the escitalopram and aripiprazole for 6 weeks. At week 10 prior to starting the adjunctive aripiprazole and week 16 (end of treatment) the subjects will receive the PET and MRI scans. The neuroimaging will consist of fMRI, a raclopride PET scan, and a fluoro-dopa PET scan. Ten normal control subjects will undergo one set of scans (fMRI,raclopride and FOPA PET scans) to use as comparison group.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Major Depressive following DSM-IV criteria

- At least one failed adequate dose trial of an antidepressant

- Medication free or antidepressant wash-out of at least two weeks or 5 half-lives

whichever is longer

- Lexapro allowed

Exclusion Criteria:

- Smokers

- Suicidality

- History of anxiety disorder

- Pregnant or lactating women or sexually active women of child bearing potential who

are not using medically accepted means of contraception

- Organic mental disorders

- Substance abuse/dependence

- Schizophrenia and psychotic disorders

- Panic disorder, generalized anxiety disorder, bulimia nervosa and anorexia nervosa

- Other current forms of treatment for depression

- Demonstrated previous inadequate antidepressant response to ECT

- ECT for the current episode of depression

- Hospitalized within four weeks of the study

- MAO-I treatment within two weeks of enrollment.

- Known allergy, hypersensitivity or previous unresponsiveness to aripiprazole or known

intolerance to any study medication

- Positive drug screen

- History of any thyroid pathology

- History of serotonin syndrome or neuroleptic malignant syndrome

- History of seizure disorder

- Participation in a trial using PET scans in the past twelve months

Locations and Contacts

Martha E Cornell, BSN, Phone: 314-362-0038, Email: cornellm@wustl.edu

Washington University in St. Louis, School of Medicine, St. Louis, Missouri 63110, United States; Recruiting
Martha E Cornell, BSN, Phone: 314-362-0038
Charles R Conway, MD, Principal Investigator
Additional Information

Starting date: May 2009
Last updated: August 8, 2011

Page last updated: August 20, 2015

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