- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00125931
Effects of Pentazocine on Manic Symptoms
August 25, 2014 updated by: Beth L. Murphy MD, PhD, Mclean Hospital
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pentazocine/Talwin
Talwin NX
|
Talwin NX 50mg po twice
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
YMRS Scores
Time Frame: Each morning of the three-day study
|
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.
|
Each morning of the three-day study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1016/s0306-4522(03)00397-x.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
August 1, 2005
First Submitted That Met QC Criteria
August 1, 2005
First Posted (Estimate)
August 2, 2005
Study Record Updates
Last Update Posted (Estimate)
September 4, 2014
Last Update Submitted That Met QC Criteria
August 25, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005P-001260
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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