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OpenTrials
Completed

NCT Number: NCT00296777

Treatment of Depression Following Multiple Brain Tests

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

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Depression Evaluation Service - New York State Psychiatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Escitalopram

Drug

8 weeks: up to 40 mg/day

Other names: Lexapro

bupropion

Drug

8 weeks: up to 450 mg/day (for patients without history of seizures or risk for developing seizures.

Other names: Wellbutrin

Imipramine

Drug

8 weeks: up to 300mg/day

*if patient does not have contraindication.

Other names: Tofranil, Pressamine

Primary outcomes

  1. Hamilton Depression Scale (HAM-D)

    Time frame: 7 mos.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Feb 27, 2006
Registry last updated
Apr 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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