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

NCT00953745 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2018-04-19

Study results available
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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 (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.

Conditions

Interventions

DRUG

Escitalopram

All subjects will begin on escitalopram and placebo for 8 weeks

DRUG

Aripiprazole

Subjects who fail to respond to Escitalopram will continue on Escitalopram and augment with active Aripiprazole.

DRUG

Placebo Capsule

All subjects will begin on escitalopram and placebo capsule for 8 weeks.

DRUG

Placebo Tablet

After 8 weeks, subjects will be given a 2 week supply of escitalopram and placebo tablet.

Sponsors & Collaborators

Principal Investigators

  • Charles R Conway, MD · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-06-30
Completion
2012-12-31

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00953745 on ClinicalTrials.gov