Status:
TERMINATED
Galantamine Augmentation of Escitalopram for Treatment of Depression
Lead Sponsor:
Indiana University School of Medicine
Conditions:
Depression
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
HYPOTHESES/OBJECTIVES Aim 1: To investigate whether patients treated with escitalopram in combination with galantamine will show a significantly greater improvement of depression compared to patients...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00423969
Start Date
November 1 2003
End Date
September 1 2005
Last Update
January 18 2007
Active Locations (1)
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1
IU Adult Psychiatric Clinic
Indianapolis, Indiana, United States, 46202