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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: August 25, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Drug: Talwin Nx
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Inpatient Clinical Trial Examining the Effects of Pentazocine on Manic Symptoms

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Mania Symptoms Using MACS [ Time Frame: hourly for 6 hours after first dose of pentazocine; hour 0 is the baseline score and also when first dose of pentazocine was administered ] [ Designated as safety issue: No ]
    Assessment of current mania symptoms using Mania Acute Change Scale (MACS). All 20 questions on the scale have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean MACS score totals were reported, with the total ranging from 0-80. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and higher lower intensity.


Secondary Outcome Measures:
  • YMRS Scores [ Time Frame: Each morning of the three-day study ] [ Designated as safety issue: No ]
    Assessment of current mania symptoms using YMRS. All questions have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean YMRS scores were reported, with the total ranging from 0-44. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and higher lower intensity.


Enrollment: 10
Study Start Date: September 2005
Study Completion Date: December 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pentazocine/Talwin
Talwin NX
Drug: Talwin Nx
Talwin NX 50mg po twice
Other Name: Pentazocine

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125931

Sponsors and Collaborators
Mclean Hospital
Stanley Medical Research Institute
Investigators
Principal Investigator: Beth L Murphy, MD, PhD Mclean Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Beth L. Murphy MD, PhD, Principal Investigator, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00125931     History of Changes
Other Study ID Numbers: 2005P-001260
Study First Received: August 1, 2005
Results First Received: October 22, 2012
Last Updated: August 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
bipolar disorder
mania
manic state
opiate
kappa

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pentazocine
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014