Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369915
Status:
TERMINATED
Last Update Posted:
2016-11-10
First Post:
2006-08-29
Brief Title:
The Antidepressant Efficacy of the Anticholinergic Scopolamine
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Antidepressant Efficacy of the Anticholinergic Scopolamine
Status:
TERMINATED
Status Verified Date:
2016-09
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:
A previous study showed that the intravenous administration of scopolamine produces antidepressant effects This study is designed to determine if other routes of administration of scopolamine produce antidepressant effects
Detailed Description:
Despite the availability of a wide range of antidepressant drugs clinical trials indicate that 30 to 40 of patients with major depression fail to respond to first-line antidepressant treatment despite adequate dosage duration and compliance Moreover in those patients who do experience symptomatic relief following conventional anti-depressant treatment clinical improvement is not evident for 3-4 weeks Thus there is a clear need to develop novel and improved therapeutics for unipolar and bipolar depression
The cholinergic system is one of the neurotransmitter systems implicated in the pathophysiology of mood disorders Evidence suggests that during major depressive episodes the cholinergic system is hypersensitive to acetylcholine Agents that enhance muscarinic cholinergic receptor function increase depressive symptoms in depressed subjects and can produce symptoms of depression in healthy individuals The preclinical literature more specifically implicates the muscarinic receptors and indicates that the use of muscarinic antagonists in the context of animal models of depression results in improvement in the behavioral analogs of depression
Preliminary results obtained under protocol 3-M-0108 provide strong evidence for the potential effectiveness of the anticholinergic scopolamine in rapidly producing clinically significant antidepressant effects We observed large reductions in Montgomery-Asberg Depression Rating Scale MADRS scores that occurred over hoursdays following iv infusion of scopolamine which stood in marked contrast to the 3-4 week period generally required for conventional therapies Moreover these improvements were observed in subjects who had been nonresponsive or incompletely responsive to conventional antidepressant therapies highlighting the potential for this treatment to benefit a larger percentage of individuals with depression The goal of this research project is to perform a clinical trial to evaluate the efficacy of the muscarinic cholinergic receptor antagonist scopolamine administered via transdermal patch on clinical symptoms of depression
The cholinergic system is one of the neurotransmitter systems implicated in the pathophysiology of mood disorders Evidence suggests that during major depressive episodes the cholinergic system is hypersensitive to acetylcholine Agents that enhance muscarinic cholinergic receptor function increase depressive symptoms in depressed subjects and can produce symptoms of depression in healthy individuals The preclinical literature more specifically implicates the muscarinic receptors and indicates that the use of muscarinic antagonists in the context of animal models of depression results in improvement in the behavioral analogs of depression
Preliminary results obtained under protocol 3-M-0108 provide strong evidence for the potential effectiveness of the anticholinergic scopolamine in rapidly producing clinically significant antidepressant effects We observed large reductions in Montgomery-Asberg Depression Rating Scale MADRS scores that occurred over hoursdays following iv infusion of scopolamine which stood in marked contrast to the 3-4 week period generally required for conventional therapies Moreover these improvements were observed in subjects who had been nonresponsive or incompletely responsive to conventional antidepressant therapies highlighting the potential for this treatment to benefit a larger percentage of individuals with depression The goal of this research project is to perform a clinical trial to evaluate the efficacy of the muscarinic cholinergic receptor antagonist scopolamine administered via transdermal patch on clinical symptoms of depression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-M-0234 | None | None | None |