Magnetic Resonance Imaging Study of Geriatric Depression

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00245557
• Other study ID #: 2004P-002540
• Status: Completed
• Phase: N/A
• First received: October 27, 2005
• Last updated: April 6, 2015
• Start date: November 2004
• Est. completion date: August 2008

Study information

• Verified date: April 2015
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 89 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Sertraline
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.

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Mclean Hospital	National Alliance for Research on Schizophrenia and Depression, Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HAM-D 17 (Hamilton Depression Rating Scale)	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).	baseline at study entry week 0	No
Primary	Geriatric Depression Scale	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).	baseline at study entry week 0	No
Primary	MRS (Magnetic Resonance Spectroscopy)		at week 13	No