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Sponsors and Collaborators: |
Mclean Hospital Stanley Medical Research Institute |
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Information provided by: | Mclean Hospital |
ClinicalTrials.gov Identifier: | NCT00125931 |
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 |
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Bipolar Disorder |
Drug: Talwin Nx |
Phase II |
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 |
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 |
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1: Experimental
Talwin NX
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Drug: Talwin Nx
Talwin NX 50mg po twice
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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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
McLean Hospital | |
Belmont, Massachusetts, United States, 02478 |
Principal Investigator: | Beth L Murphy, MD, PhD | Mclean Hospital |
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 |
bipolar disorder mania manic state opiate |
kappa mania manic state |
Affective Disorders, Psychotic Mental Disorders Bipolar Disorder |
Mood Disorders Psychotic Disorders Pentazocine |
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 |