Overview

Galantamine Augmentation of Escitalopram for Treatment of Depression

Status:
Terminated
Trial end date:
2005-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to investigate whether the addition of galantamine to a commonly used antidepressant, escitalopram (Lexapro), will be useful in the treatment of memory and other thinking problems that are frequently seen in depression. At present, galantamine is approved for use in the treatment of Alzheimer's disease or dementia, but not for use for the treatment of depression in younger patients. Possible genetic effects of depressed individuals will also be studied. This study is involved in collecting blood from patients with depression. DNA, the genetic material in our cells, will be obtained from these blood samples. The DNA will be studied to determine the contribution of different genes to the development of depression. These blood samples are extremely useful to researchers who are trying to determine the genetic risk factors that may lead to depression.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Indiana University School of Medicine
Treatments:
Citalopram
Dexetimide
Galantamine
Criteria
Inclusion Criteria:

1. Age 18 - 60 years of age inclusive

2. Satisfy DSM-IV-TR criteria for Major Depression

3. RAVLT scores decreased from normative mean for age

4. 17 item HDRS rating > 18

5. Give informed consent as approved by local IRB

6. On no antidepressants or wanting to be tapered off current antidepressant medication
due to side effects or inefficacy; and

7. Not on monoamine oxidase inhibitors (MAOIs) for 3 weeks before start of the study.

Exclusion Criteria:

1. Comorbid psychotic disorder such as schizophrenia or schizoaffective disorder

2. Significant suicidal or homicidal risk

3. Clinically significant medical illness

4. Allergy or intolerance to escitalopram or galantamine

5. Woman of child bearing age (except if surgically sterile or have had tubal ligation)

6. Satisfy criteria for substance dependence within 6 months prior to start of the study

7. History of intolerance to escitalopram or galantamine; and

8. On any medication with significant adverse interaction with either escitalopram or
galantamine.