Magnetic Resonance Imaging Study of Geriatric Depression
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Nuclear Magnetic Resonance Imaging Study of Treatment With Sertraline in Geriatric Depression|
- 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).
- 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).
- 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)
|Study Start Date:||November 2004|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
No Intervention: Healthy Controls
Healthy Controls undergo MRI and neuropsychological testing
Depressed subjects receive experimental 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 Name: Zoloft
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245557
|United States, Massachusetts|
|Belmont, Massachusetts, United States, 02478|
|Principal Investigator:||Brent Forester, M.D||Mclean Hospital|