Magnetic Resonance Imaging Study of Geriatric Depression

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Sertraline

• Registration Number: NCT00245557
• Lead Sponsor: Mclean Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-10-27
• Study First Submitted QC: 2005-10-27
• Study First Posted: 2005-10-28
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2009-09-16
• Results First Submitted QC: 2010-02-08
• Results First Posted: 2010-02-26
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Depressed	Sertraline	Depressed subjects receive experimental drug

Primary Outcome Measures

Name	Time	Method
HAM-D 17 (Hamilton Depression Rating Scale)	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).
Geriatric Depression Scale	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).
Phosphorus Magnetic Resonance Spectroscopy (31P-MRS)	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)

Trial Locations

Locations (1)

McLean Hospital; 🇺🇸 Belmont, Massachusetts, United States