Effects of Pentazocine on Manic Symptoms - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 1, 2005

Last Updated Date

February 27, 2009

Start Date ^†

September 2005

Current Primary Outcome Measures ^†

mania rating scale [ Time Frame: hourly-daily ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

mania rating scale
mania symptoms self-report

Change History

Complete list of historical versions of study NCT00125931 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

hours of sleep [ Time Frame: nightly ] [ Designated as safety issue: No ]
use of adjunctive 'as needed' medications [ Time Frame: daily ] [ Designated as safety issue: No ]
mania symptoms self-report [ Time Frame: hourly-daily ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

hours of sleep
use of adjunctive 'as needed' medications

Descriptive Information

Brief Title ^†

Effects of Pentazocine on Manic Symptoms

Official Title ^†

Inpatient Clinical Trial Examining the Effects of Pentazocine on Manic Symptoms

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 to/from manic and depressive states in bipolar disorder. One problem with most of the currently available opiate medications is that they can produce addiction/dependence. 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 to/from manic and depressive states in bipolar disorder. The clinical use of opiate medications has been limited by their abuse/dependence potential. Studies of opiate receptor subtypes have raised the possibility that medications targeting the kappa/dynorphin system could be used to target mood symptoms with reduced/limited addiction potential. Rodent studies at Mclean indicate that kappa-agonists have pro-depressant effects and kappa-antagonists have anti-depressant effects. In addition, antimanic/antipsychotic 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 Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^†

Bipolar Disorder

Intervention ^†

Drug: Talwin Nx

Study Arms / Comparison Groups

Experimental: Talwin NX

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

December 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Young Mania Rating Scale (YMRS) greater than 14
Inpatient

Exclusion Criteria:

History of opiate abuse/dependence
Recent history of substance abuse
Pregnancy
Unstable medical issues
Use of opiate medications for pain management

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00125931

Responsible Party

Beth Murphy MD, PhD, McLean Hospital

Secondary IDs ^††

Study Sponsor ^†

Mclean Hospital

Collaborators ^††

Stanley Medical Research Institute

Investigators ^†

Principal Investigator:

Beth L Murphy, MD, PhD

Mclean Hospital

Information Provided By

Mclean Hospital

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.