Trial Outcomes & Findings for Magnetic Resonance Imaging Study of Geriatric Depression (NCT NCT00245557)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

43 participants

Primary outcome timeframe

baseline at study entry week 0

Results posted on

2017-03-30

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Controls (Baseline) Healthy Controls undergo MRI and neuropsychological testing	Depressed (Baseline) Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
Overall Study STARTED	17	26
Overall Study COMPLETED	11	10
Overall Study NOT COMPLETED	6	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Magnetic Resonance Imaging Study of Geriatric Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Controls (Baseline) n=17 Participants Healthy Controls undergo MRI and neuropsychological testing	Depressed (Baseline) n=26 Participants Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Age, Continuous	72.6 years STANDARD_DEVIATION 4.8 • n=5 Participants	69.3 years STANDARD_DEVIATION 10.7 • n=7 Participants	70.6 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	26 participants n=7 Participants	43.0 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Healthy Controls (Baseline) n=11 Participants Healthy Controls undergo MRI and neuropsychological testing	Depressed (Baseline) n=10 Participants Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.	Post-treatment Depressed
HAM-D 17 (Hamilton Depression Rating Scale)	1.0 Units on a scale Standard Deviation 1.1	18.5 Units on a scale Standard Deviation 6.5	—

PRIMARY outcome

Timeframe: baseline at study entry week 0

Population: Not all subjects included in MRS analysis had baseline GDS data.

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).

Outcome measures

Outcome measures
Measure	Healthy Controls (Baseline) n=10 Participants Healthy Controls undergo MRI and neuropsychological testing	Depressed (Baseline) n=9 Participants Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.	Post-treatment Depressed
Geriatric Depression Scale	0.6 Units on a scale Standard Deviation .51	9.1 Units on a scale Standard Deviation 1.6	—

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Healthy Controls (Baseline) n=10 Participants Healthy Controls undergo MRI and neuropsychological testing	Depressed (Baseline) n=9 Participants Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.	Post-treatment Depressed n=8 Participants
Phosphorus Magnetic Resonance Spectroscopy (31P-MRS) bNTP	.0432 Spectroscopic Index Standard Error .0007	.0397 Spectroscopic Index Standard Error .0006	.0410 Spectroscopic Index Standard Error .0007
Phosphorus Magnetic Resonance Spectroscopy (31P-MRS) PCr	.0496 Spectroscopic Index Standard Error .0009	.0512 Spectroscopic Index Standard Error .0008	.0515 Spectroscopic Index Standard Error .0009
Phosphorus Magnetic Resonance Spectroscopy (31P-MRS) Total NTP	.1509 Spectroscopic Index Standard Error .0028	.1420 Spectroscopic Index Standard Error .0029	.1396 Spectroscopic Index Standard Error .0028

Adverse Events

Healthy Controls (Baseline)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Depressed (Baseline)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Healthy Controls (Baseline) n=17 participants at risk Healthy Controls undergo MRI and neuropsychological testing	Depressed (Baseline) n=26 participants at risk Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
Gastrointestinal disorders Loose stools/ Diahrrea	0.00% 0/17 • 6 years, 2 months	15.4% 4/26 • Number of events 11 • 6 years, 2 months
Gastrointestinal disorders Nausea	0.00% 0/17 • 6 years, 2 months	15.4% 4/26 • Number of events 4 • 6 years, 2 months
Gastrointestinal disorders Constipation	0.00% 0/17 • 6 years, 2 months	7.7% 2/26 • Number of events 2 • 6 years, 2 months
General disorders Dry Mouth	0.00% 0/17 • 6 years, 2 months	11.5% 3/26 • Number of events 5 • 6 years, 2 months
Nervous system disorders Dizziness	0.00% 0/17 • 6 years, 2 months	11.5% 3/26 • Number of events 3 • 6 years, 2 months
Eye disorders Blurred Vision	0.00% 0/17 • 6 years, 2 months	7.7% 2/26 • Number of events 2 • 6 years, 2 months
Nervous system disorders Headaches	0.00% 0/17 • 6 years, 2 months	7.7% 2/26 • Number of events 2 • 6 years, 2 months

Additional Information

Brent Forester MD

McLean Hospital

Phone: 617-855-3622

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place