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Treatment of Depression Following Multiple Brain Tests

This study has been completed.
Information provided by (Responsible Party):
New York State Psychiatric Institute Identifier:
First received: February 23, 2006
Last updated: April 26, 2012
Last verified: April 2012

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

Condition Intervention Phase
Major Depression
Drug: Escitalopram
Drug: Bupropion
Drug: Imipramine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Hamilton Depression Scale (HAM-D) [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Beck Depression Inventory (BDI) [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • Clinical Global Impression (CGI) [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • Patient Global Impression (PGI) [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • Inventory of Depressive Symptoms (IDS) [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • Edinburgh Handedness Inventory [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • Chapman Pleasure Scale [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]
  • Spielberger State/Trait Anxiety Inventory [ Time Frame: 7 mos. ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: December 2004
Study Completion Date: December 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Additional Information:
Responsible Party: New York State Psychiatric Institute Identifier: NCT00296777     History of Changes
Other Study ID Numbers: #4781
Study First Received: February 23, 2006
Last Updated: April 26, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Adrenergic Agents
Adrenergic Uptake Inhibitors
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents, Tricyclic
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions processed this record on November 20, 2014