Treatment of Depression Following Multiple Brain Tests

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00296777
First received: February 23, 2006
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Major Depression
Dysthymia
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00296777

Locations
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
Investigators
Principal Investigator: Jonathan W. Stewart, MD. New York State Psychiatric Institute - Columbia University Department of Psychiatry
  More Information

Additional Information:
Publications:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov 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
Dysthymia
f-MRI
Escitalopram
Bupropion
Imipramine
Neuropsychologic test
Dichotic listening
EEG
ERP

Additional relevant MeSH terms:
Depression
Depressive Disorder
Dysthymic Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Imipramine
Bupropion
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents

ClinicalTrials.gov processed this record on August 21, 2014