Effects of Pentazocine on Manic Symptoms

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Beth L. Murphy MD, PhD, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00125931
First received: August 1, 2005
Last updated: April 20, 2012
Last verified: April 2012

August 1, 2005
April 20, 2012
September 2005
August 2008   (final data collection date for primary outcome measure)
mania rating scale [ Time Frame: hourly-daily ] [ Designated as safety issue: No ]
  • mania rating scale
  • mania symptoms self-report
Complete list of historical versions of study NCT00125931 on ClinicalTrials.gov Archive Site
  • 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 ]
  • hours of sleep
  • use of adjunctive 'as needed' medications
Not Provided
Not Provided
 
Effects of Pentazocine on Manic Symptoms
Inpatient Clinical Trial Examining the Effects of Pentazocine on Manic Symptoms

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Bipolar Disorder
Drug: Talwin Nx
Talwin NX 50mg po twice
Experimental: 1
Talwin NX
Intervention: Drug: Talwin Nx

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
December 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00125931
2005P-001260
No
Beth L. Murphy MD, PhD, Mclean Hospital
Mclean Hospital
Stanley Medical Research Institute
Principal Investigator: Beth L Murphy, MD, PhD Mclean Hospital
Mclean Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP