Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-30 @ 7:03 AM
Study NCT ID:
NCT00423969
Status:
TERMINATED
Last Update Posted:
2007-01-18
First Post:
2005-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Galantamine Augmentation of Escitalopram for Treatment of Depression
Sponsor:
Indiana University School of Medicine
Organization:
Study Overview
Official Title:
Galantamine Augmentation of Escitalopram for Treatment of Depression Associated Cognitive Impairment in Outpatients - A Randomized Single Blind Clinical Trial
Status:
TERMINATED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 45-869-96 | None | None | View |