Galantamine Augmentation of Escitalopram for Treatment of Depression

Stopped early · Phase 4

Conditions studied: Depression

In brief

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.

Key facts

Study ID

NCT00423969

Run by

Indiana University

People needed

20

Starts

2003-11-01

Expected to finish

2005-09-01

Last updated by the study team

2007-01-18

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 - 60 years of age inclusive
• Satisfy DSM-IV-TR criteria for Major Depression
• RAVLT scores decreased from normative mean for age
• 17 item HDRS rating > 18
• Give informed consent as approved by local IRB
• On no antidepressants or wanting to be tapered off current antidepressant medication due to side effects or inefficacy; and
• Not on monoamine oxidase inhibitors (MAOIs) for 3 weeks before start of the study.

You may not qualify if…

• Comorbid psychotic disorder such as schizophrenia or schizoaffective disorder
• Significant suicidal or homicidal risk
• Clinically significant medical illness
• Allergy or intolerance to escitalopram or galantamine
• Woman of child bearing age (except if surgically sterile or have had tubal ligation)
• Satisfy criteria for substance dependence within 6 months prior to start of the study
• History of intolerance to escitalopram or galantamine; and
• On any medication with significant adverse interaction with either escitalopram or galantamine.

Where it is running

• IU Adult Psychiatric Clinic — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.