Treatment Resistant Geriatric Depression in Primary Care

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 functioning than older adults with depression.

Conditions

• Major Depressive Disorder

Interventions

DRUG

Memantine

Dosing Form: Tablet Dosage: 5mg, 10 mg Description: Memantine hydrochloride (Namenda®), a low to moderate affinity uncompetitive (open-channel) NMDA antagonist, is manufactured and supplied by Forest Laboratories, Incorporated. Only the subjects in the depression group will receive the study drug memantine HCl. Per psychiatrist's instructions, subjects may remain on the maximum dosage of memantine HCl allowed by the study protocol for a given week, or reduce the dosage if concerns regarding tolerability arise. The dosage of memantine HCl cannot be increased more rapidly than the dosing schedule listed below. Memantine HCl Dosing Schedule: 5 mg qAM week 1 5 mg qAM and 5 mg qHS for week 2 10 mg qAM and 5 mg qHS for week 3 10 mg BID for week 4, 5, 6, 7, and 8

Sponsors & Collaborators

• Cambridge Health Alliance

  collaborator OTHER

• Harvard University

  collaborator OTHER

• Mclean Hospital

  lead OTHER

Principal Investigators

• Brent P Forester, M.D. · Mclean Hospital

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

55 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2012-04-30

Completion

2012-04-30

Countries

• United States

Study Locations