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Completed

NCT Number: NCT00245557

Magnetic Resonance Imaging Study of Geriatric Depression

The purpose of this study was to use Magnetic Resonance Images to further our understanding of predictors and markers of treatment response and non-response in geriatric depression. We hypothesized that concentrations of high energy metabolites would be lower in depressed elderly compared to non-depressed.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

55 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • DSM- IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition) diagnostic criteria for major depressive disorder
  • Hamilton Depression Scale- 17 item version score of 18 or higher
  • Must speak English
  • Women must be post-menopausal

Exclusion criteria

  • A current or pervious psychiatric disorder other than MDD
  • A current unstable medical condition
  • A pacemaker or metal implant
  • History of alcohol or drug dependence or abuse within the past year
  • Current prescription of excluded medications
  • Use of a drug within the last 30 days that was not approved for use by governmental authorities.
  • If you or a family member works at McLean Hospital

Treatment and study plan

Sertraline

Drug

Oral Sertraline Dosage started at 25 mg a day, with increases up to maximum dosage strength of 200 mg a day.

Duration of treatment was 12 weeks.

Other names: Zoloft

Primary outcomes

  1. HAM-D 17 (Hamilton Depression Rating Scale)

    Time frame: baseline at study entry week 0

    This is a depression severity rating scale measuring symptoms of depression including mood, sleep, appetite, energy, motivation, guilt, suicidal ideation, concentration, physical complaints, paranoia, anxiety, effect on daily functioning and awareness of illness.

    Scale is from 0 (no depression symptoms) up to a maximum of 66 (severe depression symptoms).

  2. Geriatric Depression Scale

    Time frame: baseline at study entry week 0

    This is a depression severity rating scale measuring symptoms of depression. Scale is from 0 (no depression symptoms) up to a maximum of 15 (severe depression symptoms).

  3. Phosphorus Magnetic Resonance Spectroscopy (31P-MRS)

    Time frame: at week 0 for both control and depressed, and at week 12 for depressed

    The primary outcome is a phosphorus magnetic resonance spectroscopy (31P-MRS) signal quantified using a spectral time-domain fitting program based on the Marquadt-Levenberg non-linear, least-squares algorithm, that incorporates prior knowledge of spectral peak assignments, chemical shifts and J-coupling constants. Least squares means were calculated for average total signal using linear mixed effects models. Results are expressed as a spectroscopic index.

    beta-nucleoside triphosphate (bNTP) Phosphocreatine (PCr) Total nucleoside triphosphate (NTP)

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Collaborators

  • National Alliance for Research on Schizophrenia and Depression
  • Pfizer

Registry information

Official study title

Nuclear Magnetic Resonance Imaging Study of Treatment With Sertraline in Geriatric Depression

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Oct 28, 2005
Registry last updated
Mar 30, 2017

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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