Effects of Pentazocine on Manic Symptoms - Full Text View

Sponsors and Collaborators:	Mclean Hospital Stanley Medical Research Institute
Information provided by:	Mclean Hospital
ClinicalTrials.gov Identifier:	NCT00125931

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 II

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Talwin Nx Pentazocine Pentazocine hydrochloride Pentazocine lactate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Inpatient Clinical Trial Examining the Effects of Pentazocine on Manic Symptoms

Further study details as provided by Mclean Hospital:

Primary Outcome Measures:

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

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 ]

Enrollment:	10
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Talwin NX	Drug: Talwin Nx Talwin NX 50mg po twice

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

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

Locations

United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478

Sponsors and Collaborators

Mclean Hospital

Stanley Medical Research Institute

Investigators

Principal Investigator:

Beth L Murphy, MD, PhD

Mclean Hospital

More Information

McLean hospital website, with links to research. This link exits the ClinicalTrials.gov site

Publications:

Ma J, Ye N, Lange N, Cohen BM. Dynorphinergic GABA neurons are a target of both typical and atypical antipsychotic drugs in the nucleus accumbens shell, central amygdaloid nucleus and thalamic central medial nucleus. Neuroscience. 2003;121(4):991-8.

Carlezon WA Jr, Beguin C, DiNieri JA, Baumann MH, Richards MR, Todtenkopf MS, Rothman RB, Ma Z, Lee DY, Cohen BM. Depressive-like effects of the kappa-opioid receptor agonist salvinorin A on behavior and neurochemistry in rats. J Pharmacol Exp Ther. 2006 Jan;316(1):440-7. Epub 2005 Oct 13.

Mague SD, Pliakas AM, Todtenkopf MS, Tomasiewicz HC, Zhang Y, Stevens WC Jr, Jones RM, Portoghese PS, Carlezon WA Jr. Antidepressant-like effects of kappa-opioid receptor antagonists in the forced swim test in rats. J Pharmacol Exp Ther. 2003 Apr;305(1):323-30.

Todtenkopf MS, Marcus JF, Portoghese PS, Carlezon WA Jr. Effects of kappa-opioid receptor ligands on intracranial self-stimulation in rats. Psychopharmacology (Berl). 2004 Apr;172(4):463-70. Epub 2004 Jan 16.

Responsible Party:	McLean Hospital ( Beth Murphy MD, PhD )
Study ID Numbers:	2005P-001260
Study First Received:	August 1, 2005
Last Updated:	January 17, 2008
ClinicalTrials.gov Identifier:	NCT00125931
Health Authority:	United States: Institutional Review Board

Keywords provided by Mclean Hospital:

bipolar disorder
mania
manic state
opiate

kappa
mania
manic state

Study placed in the following topic categories:

Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder

Mood Disorders
Psychotic Disorders
Pentazocine

Additional relevant MeSH terms:

Adjuvants, Anesthesia
Sensory System Agents
Therapeutic Uses
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants

Narcotics
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009