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Neuroimaging Of Treatment Effects in Treatment-Resistant Depression

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ClinicalTrials.gov Identifier: NCT00953745
Recruitment Status : Unknown
Verified August 2011 by Washington University School of Medicine.
Recruitment status was:  Recruiting
First Posted : August 6, 2009
Last Update Posted : August 10, 2011
Information provided by:
Washington University School of Medicine

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 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.

Condition or disease Intervention/treatment
Major Depressive Disorder Drug: escitalopram and adjunctive aripiprazole and placebo

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2009
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: escitalopram and adjunctive aripiprazole and placebo
    escitalopram 20 mg per day plus placebo for 10 weeks followed by escitalopram 20mg and aripiprazole 10 mg for 6 weeks
    Other Names:
    • escitalopram
    • Lexapro
    • aripiprazole
    • Abilify

Primary Outcome Measures :
  1. 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. [ Time Frame: PET, fMRI and MADRS testing done at start of adjuctive aripiprazole and after 6 weeks of combined therapy ]

Secondary Outcome Measures :
  1. Correlation of D2binding before and after adjunctive aripiprazole with emergence of extrapyramidal symptoms and akathisia. [ Time Frame: PET scans and EPS assessment conducted at start of aripiprazole and after 6 weeks of combination therapy. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00953745

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

United States, Missouri
Washington University in St. Louis, School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Martha E Cornell, BSN    314-362-0038      
Principal Investigator: Charles R Conway, MD         
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Charles R Conway, MD Washington University School of Medicine

Responsible Party: Charles R. Conway, MD, Washington University in St. Louis
ClinicalTrials.gov Identifier: NCT00953745     History of Changes
Other Study ID Numbers: 2009-0419
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: August 10, 2011
Last Verified: August 2011

Keywords provided by Washington University School of Medicine:
Mood disorder
PET Scan

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists