Effects of Pentazocine on Manic Symptoms

NCT00125931 | Completed Phase 2 Results

• 1 other identifier: 2005P-001260
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bipolar Disorder

Keywords

bipolar disorder; mania; manic state; opiate; kappa

Outcome Measures

Primary Outcomes (1)

• Mania Symptoms Using MACS

  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.

  hourly for 6 hours after first dose of pentazocine; hour 0 is the baseline score and also when first dose of pentazocine was administered

Secondary Outcomes (1)

• YMRS Scores

  Each morning of the three-day study

Study Arms (1)

Pentazocine/Talwin

EXPERIMENTAL

Talwin NX

Drug: Talwin Nx

Interventions

Talwin Nx DRUG

Talwin NX 50mg po twice

Also known as: Pentazocine

Pentazocine/Talwin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Young Mania Rating Scale (YMRS) greater than 14
• Inpatient

You may not qualify if:

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

Sponsors & Collaborators

• Mclean Hospital: lead
• Stanley Medical Research Institute: collaborator

Related Publications (5)

• 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. doi: 10.1016/s0306-4522(03)00397-x.

  PMID: 14580949 BACKGROUND

• 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. doi: 10.1124/jpet.105.092304. Epub 2005 Oct 13.

  PMID: 16223871 BACKGROUND

• 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. doi: 10.1124/jpet.102.046433.

  PMID: 12649385 BACKGROUND

• 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. doi: 10.1007/s00213-003-1680-y. Epub 2004 Jan 16.

  PMID: 14727002 BACKGROUND

• Cohen BM, Murphy B. The effects of pentazocine, a kappa agonist, in patients with mania. Int J Neuropsychopharmacol. 2008 Mar;11(2):243-7. doi: 10.1017/S1461145707008073. Epub 2007 Sep 26.

  PMID: 17897484 RESULT

Related Links

• McLean hospital website, with links to research.

MeSH Terms

Conditions

Bipolar Disorder; Mania

Interventions

talwin Nx; Pentazocine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzomorphans; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Small number of participants in open-label trial.

Results Point of Contact

• Title: Beth Murphy, MD PhD
• Organization: McLean Hospital

BMurphy5@partners.org

617-855-2297

Study Officials

• Beth L Murphy, MD, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2005
• First Posted: August 2, 2005
• Study Start: September 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 4, 2014
• Results First Posted: September 4, 2014

Record last verified: 2014-08