Treatment of Depression Following Multiple Brain Tests

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00296777
Recruitment Status : Completed
First Posted : February 27, 2006
Last Update Posted : April 27, 2012
Information provided by (Responsible Party):
New York State Psychiatric Institute

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

Condition or disease Intervention/treatment Phase
Major Depression Dysthymia Drug: Escitalopram Drug: Bupropion Drug: Imipramine Phase 4

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  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Medication Treatment Following Neuropsychologic, Dichotic and f-MRI Tests in Depressed Outpatients With Repeat f-MRI Following Treatment
Study Start Date : December 2004
Actual Primary Completion Date : May 2007
Actual Study Completion Date : December 2007

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 Name: 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 Name: 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 Name: Tofranil, Pressamine

Primary Outcome Measures :
  1. Hamilton Depression Scale (HAM-D) [ Time Frame: 7 mos. ]

Secondary Outcome Measures :
  1. Beck Depression Inventory (BDI) [ Time Frame: 7 mos. ]
  2. Clinical Global Impression (CGI) [ Time Frame: 7 mos. ]
  3. Patient Global Impression (PGI) [ Time Frame: 7 mos. ]
  4. Inventory of Depressive Symptoms (IDS) [ Time Frame: 7 mos. ]
  5. Edinburgh Handedness Inventory [ Time Frame: 7 mos. ]
  6. Chapman Pleasure Scale [ Time Frame: 7 mos. ]
  7. Spielberger State/Trait Anxiety Inventory [ Time Frame: 7 mos. ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00296777

United States, New York
Depression Evaluation Service - New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Principal Investigator: Jonathan W. Stewart, MD. New York State Psychiatric Institute - Columbia University Department of Psychiatry

Additional Information:
Responsible Party: New York State Psychiatric Institute Identifier: NCT00296777     History of Changes
Other Study ID Numbers: #4781
First Posted: February 27, 2006    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012

Keywords provided by New York State Psychiatric Institute:
Major Depression
Neuropsychologic test
Dichotic listening

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