Treatment of Depression Following Multiple Brain Tests

April 26, 2012 updated by: New York State Psychiatric Institute

Medication Treatment Following Neuropsychologic, Dichotic and f-MRI Tests in Depressed Outpatients With Repeat f-MRI Following Treatment

The main purpose of this study is to correlate brain testing with treatment outcome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

40 medication-free Depressed Patients will receive a battery of neuropsychologic tests, standard dichotic listening tests, EEG, ERP and an f-MRI while performing a neuropsychologic test, the Simon. Once testing is completed, patients will be treated in an open treatment trial of SSRI. Non-responders will then receive Bupropion followed by Tricyclic Antidepressant if still depressed. While our main purpose is to correlate imaging testing with other measures of brain functioning, we also intend to see whether f-MRI findings demonstrate specific brain areas which differ between responders and non-responders. At the end of SSRI treatment, patients will have a second f-MRI scan to investigate any changes treatment and/or response may have caused.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Depression Evaluation Service - New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • DSM-IV Major Depression or Dysthymia
  • Age 18-65
  • Physically healthy
  • Normal hearing
  • Drug-free (two weeks for most antidepressants, four weeks for Fluoxetine)

Exclusion Criteria:

  • Hearing deficit in one or both ears
  • Body metal (e.g., wire stitches, screws in bones, stainless steel hips)
  • History of Psychosis or Epilepsy
  • Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol)
  • Unstable medical problem
  • Insufficient English for neuropsychological and dichotic testing
  • Bipolar I
  • Need for wash-out from effective treatment in order to participate
  • Pregnant
  • High suicide risk
  • Currently taking (within 2 weeks; 4 weeks for Fluoxetine) antidepressants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: escitalopram
escitalopram 10 mg/d, increasing by 10 mg/week if tolerated and not remitted to maximum dose of 40 mg/d
Drug: Escitalopram
8 weeks: up to 40 mg/day
Other Names:
  • Lexapro
EXPERIMENTAL: bupropion
bupropion XL 150 mg/d, increasing by 150 mg/d if tolerated and not remitted to maximum dose of 450 mg/d
Drug: Bupropion
8 weeks: up to 450 mg/day (for patients without history of seizures or risk for developing seizures.
Other Names:
  • Wellbutrin
EXPERIMENTAL: imipramine
imipramine 50 mg/d for 3 days, then 100 mg/d for 4 days, then 150 mg/d for 3 days then 200 mg/d for 4 days then 250 mg/d for a week and then 300 mg/d thereafter, all dose increases if tolerated and not remitted
Drug: Imipramine

8 weeks: up to 300mg/day

*if patient does not have contraindication.

Other Names:
  • Tofranil, Pressamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hamilton Depression Scale (HAM-D)
Time Frame: 7 mos.
7 mos.

Secondary Outcome Measures

Outcome Measure
Time Frame
Beck Depression Inventory (BDI)
Time Frame: 7 mos.
7 mos.
Clinical Global Impression (CGI)
Time Frame: 7 mos.
7 mos.
Patient Global Impression (PGI)
Time Frame: 7 mos.
7 mos.
Inventory of Depressive Symptoms (IDS)
Time Frame: 7 mos.
7 mos.
Edinburgh Handedness Inventory
Time Frame: 7 mos.
7 mos.
Chapman Pleasure Scale
Time Frame: 7 mos.
7 mos.
Spielberger State/Trait Anxiety Inventory
Time Frame: 7 mos.
7 mos.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (ACTUAL)

May 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

February 23, 2006

First Submitted That Met QC Criteria

February 23, 2006

First Posted (ESTIMATE)

February 27, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

April 27, 2012

Last Update Submitted That Met QC Criteria

April 26, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #4781

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe