Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125931
Status:
COMPLETED
Last Update Posted:
2014-09-04
First Post:
2005-08-01
Brief Title:
Effects of Pentazocine on Manic Symptoms
Sponsor:
Mclean Hospital
Organization:
Mclean Hospital
Study Overview
Official Title:
Inpatient Clinical Trial Examining the Effects of Pentazocine on Manic Symptoms
Status:
COMPLETED
Status Verified Date:
2014-08
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 opiate neurotransmitter system is thought to be involved in many abnormal mood states Some researchers have suggested that changes in this system may trigger the switch tofrom manic and depressive states in bipolar disorder One problem with most of the currently available opiate medications is that they can produce addictiondependence A particular kind of opiate medication known as kappa-opiates may be able to produce changes in this system with much less risk of addiction This study looks at Talwin a combination of pentazocine and naloxone a medication which affects the kappa and mu opiate systems The study will examine whether two doses of Talwin affect manic symptoms in people who have been admitted to the hospital This study will give more information about the involvement of the opiate system in bipolar disorder and give important information for use in developing new treatments
Detailed Description:
Opiates have a long history of treating mood disorders Some researchers have suggested that changes in this system may trigger the switch tofrom manic and depressive states in bipolar disorder The clinical use of opiate medications has been limited by their abusedependence potential Studies of opiate receptor subtypes have raised the possibility that medications targeting the kappadynorphin system could be used to target mood symptoms with reducedlimited addiction potential Rodent studies at Mclean indicate that kappa-agonists have pro-depressant effects and kappa-antagonists have anti-depressant effects In addition antimanicantipsychotic medications regulate the activity of dynorphin cells This study is a pilot open-label investigation using Talwin a combination of pentazocine and naloxone Pentazocine is a kappa agonist and mixed mu agonist Two doses of Talwin will be given to acutely manic inpatients in a cumulative-dosing strategy Measurements of manic symptoms will be conducted before during and after administration This study will determine whether pentazocine has an immediate or sustained impact on acute mania symptoms
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