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NCT01392287 · ClinicalTrials.gov registry record · Phase 1
Treatment Resistant Geriatric Depression in Primary Care
A Phase 1 study, sponsored by Mclean Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01392287: Completed Phase 1 study, sponsored by Mclean Hospital.
NCT01392287 is a Phase 1 study that has completed, run by Mclean Hospital. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01392287, a Phase 1 study, has completed, sponsored by Mclean Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
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 funct
Primary Outcome
Are NAAG levels are lower in older adults with treatment resistant depression compared with healthy age-matched controls?
Interventions
- DRUG Memantine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
What the finished NCT01392287 record still lists
NCT01392287 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Memantine is the first listed.
NCT01392287 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01392287 about?
NCT01392287 is a clinical study titled "Treatment Resistant Geriatric Depression in Primary Care". 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 w...
What is the current status of trial NCT01392287?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2010-05. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01392287?
The interventions under investigation include: Memantine (DRUG).
Who is sponsoring clinical trial NCT01392287?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01392287's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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