Galantamine Augmentation of Escitalopram for Treatment of Depression

NCT00423969 | Terminated Phase 4

• 2 other identifiers: 0301-3545-869-96
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Depression

Keywords

Depression; Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• Decrease in depression symptoms measured by Hamilton Depression Rating Scale and Clinical Global Improvement Scale

• Improvement of cognitive measures scores:Selective Reminding Test, Trail Making Test and others

Interventions

Galantamine DRUG

Escitalopram DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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
• 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.

Sponsors & Collaborators

• Indiana University School of Medicine: lead

Study Sites (1)

IU Adult Psychiatric Clinic

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Depression; Cognitive Dysfunction

Interventions

Galantamine; Escitalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans

Study Officials

• Amit Anand, MD

  university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: January 18, 2007
• Study Start: November 1, 2003
• Study Completion: September 1, 2005
• Last Updated: January 18, 2007

Record last verified: 2007-01

Locations

US (1)