Depression Clinical Trial
Official title:
Galantamine Augmentation of Escitalopram for Treatment of Depression Associated Cognitive Impairment in Outpatients - A Randomized Single Blind Clinical Trial
Verified date | January 2007 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 20 |
Est. completion date | September 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | IU Adult Psychiatric Clinic | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decrease in depression symptoms measured by Hamilton Depression Rating Scale and Clinical Global Improvement Scale | |||
Primary | Improvement of cognitive measures scores:Selective Reminding Test, Trail Making Test and others |
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