Magnetic Resonance Imaging Study of Geriatric Depression

A study testing Sertraline in people with Major Depressive Disorder, run by Mclean Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 55 to 89 yearsHealthy volunteers can take part
Conditions the study is for: Major Depressive Disorder
What is being tested?: Sertraline
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteUnited States
Study dates: Nov 2004to Aug 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 89 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

McLean Hospital
Belmont, Massachusetts, 02478

Other trials in United States

About this study

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

Conditions: Major Depressive Disorder
Being tested: Sertraline
Keywords: Depression, Geriatric, MRI, Sertraline
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SertralineDrug
Also called Zoloft
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.

Study groups in NCT00245557
Study group	Role	What they receive
Healthy Controls	No intervention	Healthy Controls undergo MRI and neuropsychological testing
Depressed	Experimental	Depressed subjects receive experimental drug Receives: Drug: Sertraline

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: baseline at study entry week 0
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).
Measured: baseline at study entry week 0
Phosphorus Magnetic Resonance Spectroscopy (31P-MRS)
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)
Measured: at week 0 for both control and depressed, and at week 12 for depressed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2004Aug 2008

First posted28 Oct 2005 (estimated)
Study startNov 2004
Primary completionAug 2008
Study completionAug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00245557
Sponsor's protocol ID: 2004P-002540
Status last verified: Mar 2017
First submitted: 27 Oct 2005
Last updated: 30 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Harper DG, Joe EB, Jensen JE, Ravichandran C, Forester BP. Brain levels of high-energy phosphate metabolites and executive function in geriatric depression. Int J Geriatr Psychiatry. 2016 Nov;31(11):1241-1249. doi: 10.1002/gps.4439. Epub 2016 Feb 18.
PubMed 26891040

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nuclear Magnetic Resonance Imaging Study of Treatment With Sertraline in Geriatric Depression
ClinicalTrials.gov ID: NCT00245557
Acronym / sponsor ID: 2004P-002540
Conditions: Major Depressive Disorder
Keywords: Depression, Geriatric, MRI, Sertraline
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Mclean HospitalUniversity, hospital or other
Collaborators: Pfizer, National Alliance for Research on Schizophrenia and Depression
Study start: Nov 2004
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 28 Oct 2005 (estimated)
Results: Posted 26 Feb 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Healthy Controls	No intervention	–Healthy Controls undergo MRI and neuropsychological testing
Depressed	Experimental	Drug: SertralineDepressed subjects receive experimental drug

Who may qualify

Ages: 55 to 89 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SertralineAlso: ZoloftOral 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.	Drug	Depressed

Primary outcome

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)

Results and safety

Results posted to the registry on 26 Feb 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Controls (Baseline)	17	11
Depressed (Baseline)	26	10

Primary outcome: HAM-D 17 (Hamilton Depression Rating Scale)

Time frame: baseline at study entry week 0. Mean (Standard Deviation). Unit: Units on a scale

Measure	Healthy Controls (Baseline) n = 11	Depressed (Baseline) n = 10
Value	1.0 (1.1)	18.5 (6.5)

Primary outcome: Geriatric Depression Scale

Time frame: baseline at study entry week 0. Mean (Standard Deviation). Unit: Units on a scale

Measure	Healthy Controls (Baseline) n = 10	Depressed (Baseline) n = 9
Value	0.6 (.51)	9.1 (1.6)

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

Primary outcome: Phosphorus Magnetic Resonance Spectroscopy (31P-MRS)

Time frame: at week 0 for both control and depressed, and at week 12 for depressed. Least squares mean (Standard Error). Unit: Spectroscopic Index

Measure	Healthy Controls (Baseline) n = 10	Depressed (Baseline) n = 9	Post-treatment Depressed n = 8
bNTP	.0432 (.0007)	.0397 (.0006)	.0410 (.0007)
PCr	.0496 (.0009)	.0512 (.0008)	.0515 (.0009)
Total NTP	.1509 (.0028)	.1420 (.0029)	.1396 (.0028)

Adverse events

Time frame: 6 years, 2 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Controls (Baseline)	0 of 17 (0%)	0 of 17 (0%)	Not reported
Depressed (Baseline)	0 of 26 (0%)	4 of 26 (15.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26891040Harper DG, Joe EB, Jensen JE, Ravichandran C, Forester BP. Brain levels of high-energy phosphate metabolites and executive function in geriatric depression. Int J Geriatr Psychiatry. 2016 Nov;31(11):1241-1249. doi: 10.1002/gps.4439. Epub 2016 Feb 18.

Related trials for Major Depressive Disorder

RecruitingPhase 2
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Active, not recruitingPhase 1
Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder
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Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brent Forester, M.D principal investigator

Mclean Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sertraline in people with Major Depressive Disorder, run by Mclean Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HAM-D 17 (Hamilton Depression Rating Scale) (time frame: baseline at study entry week 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00245557, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017; AzTrials last refreshed its copy on 6 Nov 2026.