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Completed Phase 1 Interventional Accepts healthy volunteers

Treatment Resistant Geriatric Depression in Primary Care

ClinicalTrials.gov ID: NCT01392287

Public ClinicalTrials.gov record NCT01392287. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Treatment Resistant Geriatric Depression in Primary Care: Is NAAG (N-Acetylaspartylglutamate), Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS) at 3 Tesla, a Predictor of Treatment Response?

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study involves collaboration between McLean Hospital, Geriatric Medicine at the Cambridge Health Alliance (CHA) and other sites within the Partners and Harvard Medical School network. The investigators plan to recruit individuals 55 to 89 years old with treatment resistant depression. Someone with "treatment resistant" depression for this study may be someone who still has sad or low feelings and thoughts even though he/she is taking an antidepressant medication for at least 8 weeks to help relieve his/her depression. During the study, subjects will gradually add memantine hydrochloride in dosages up to 20 mg/day for 8 weeks to their standard antidepressant treatment. The investigators are doing this research study to help answer 3 questions: 1. Do older adults with treatment resistant Major Depression have lower levels of a chemical in the brain called NAAG than older adults without Major Depression? 2. Do older adults with naturally low NAAG levels do better on memantine hydrochloride treatment than older adults with higher amounts of this chemical on memantine hydrochloride treatment? 3. Do older adults with treatment resistant depression have more problems with memory and concentration than older adults without depression? The investigators are also interested in looking at electrical and neuronal activity of the brain, spiritual beliefs, and fatigue in relationship to depression. The investigators hypothesize that: 1. Older individuals with treatment resistant Major Depression will have lower levels of NAAG compared with age-matched older control subjects. 2. Older adults with treatment resistant depression and low NAAG levels will do better on treatment with memantine hydrochloride than older adults on memantine with higher NAAG levels. 3. Older adults with depression will do better on tests of attention and executive functioning after treatment with memantine hydrochloride. 4. Healthy controls will do better on tests of attention and executive functioning than older adults with depression.

Study identification

NCT ID
NCT01392287
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Mclean Hospital
Other
Enrollment
12 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
55 Years to 89 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 30, 2010
Primary completion
Mar 31, 2012
Completion
Mar 31, 2012
Last update posted
Jan 31, 2017

2010 – 2012

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
McLean Hospital Belmont Massachusetts 02478

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01392287, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 31, 2017 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01392287 live on ClinicalTrials.gov.

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