Galantamine Augmentation of Escitalopram for Treatment of Depression

This study has been terminated.
Sponsor:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00423969
First received: September 14, 2005
Last updated: January 17, 2007
Last verified: January 2007
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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:


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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Keywords provided by Indiana University:
Depression
Cognitive Impairment

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Galantamine
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cholinesterase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 14, 2014