Galantamine Augmentation of Escitalopram for Treatment of Depression - Full Text View

Sponsor:	Indiana University School of Medicine
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00423969

Purpose

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.

Condition	Intervention	Phase
Depression	Drug: Galantamine Drug: Escitalopram	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Galantamine Augmentation of Escitalopram for Treatment of Depression Associated Cognitive Impairment in Outpatients - A Randomized Single Blind Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Galantamine hydrobromide Escitalopram Escitalopram oxalate Galantamine

U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:

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

Estimated Enrollment:	20
Study Start Date:	November 2003
Estimated Study Completion Date:	September 2005

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 treated with escitalopram alone.

H1: Patients treated with escitalopram and galantamine combination will have significantly greater improvement on the Hamilton Depression Rating Scale (HDRS) and Clinical Global Improvement (CGI) scale compared to patients treated with escitalopram and placebo.

Aim 2: To investigate whether treatment with escitalopram in combination with galantamine will lead to a greater improvement of cognitive function in depressed patients compared to escitalopram alone.

H2: Patients treated with escitalopram and galantamine combination will have significantly greater improvement of scores on Selective Reminding Test (SRT) and Trail Making Test (TMT) than patients treated with escitalopram and placebo.

Study Design and Method:

This will be a randomized, single blind, parallel-group, placebo controlled study in which a total of 20 subjects, 10 in each arm: one arm would be escitalopram + galantamine treatment and the other arm will be escitalopram + placebo treatment. The subject will be blinded against the galantamine or placebo, but will be unblinded against escitalopram. The total duration of this study will be 10 weeks. After the baseline visit, patients will complete 8 weeks of the study medication.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423969

Locations

United States, Indiana
IU Adult Psychiatric Clinic
Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Indiana University School of Medicine

Investigators

Principal Investigator:

Amit Anand, MD

University

More Information

No publications provided

Study ID Numbers:	0301-35, 45-869-96
Study First Received:	September 14, 2005
Last Updated:	January 17, 2007
ClinicalTrials.gov Identifier:	NCT00423969 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Indiana University:

Depression
Cognitive Impairment

Additional relevant MeSH terms:

Parasympathomimetics
Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Mental Disorders
Therapeutic Uses
Dexetimide
Antidepressive Agents, Second-Generation

Antidepressive Agents
Nootropic Agents
Depression
Galantamine
Enzyme Inhibitors
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Behavioral Symptoms
Muscarinic Antagonists
Cholinesterase Inhibitors
Serotonin Agents
Autonomic Agents
Mood Disorders

ClinicalTrials.gov processed this record on November 25, 2009