Magnetic Resonance Imaging Study of Geriatric Depression
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|ClinicalTrials.gov Identifier: NCT00245557|
Recruitment Status : Completed
First Posted : October 28, 2005
Results First Posted : February 26, 2010
Last Update Posted : March 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Sertraline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nuclear Magnetic Resonance Imaging Study of Treatment With Sertraline in Geriatric Depression|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
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
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245557
|United States, Massachusetts|
|Belmont, Massachusetts, United States, 02478|
|Principal Investigator:||Brent Forester, M.D||Mclean Hospital|