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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: | NCT00431184 |
Pilot data indicates that pentazocine decreases manic symptoms in hospitalized individuals. To follow up these initial findings, we plan to conduct a larger, more rigorous, double-blind study. We will examine whether pentazocine, an agent with kappa-opiate activity, decreases manic symptoms.
Condition | Intervention | Phase |
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Bipolar Disorder Schizoaffective Disorder Manic Disorder Mania Manic State |
Drug: pentazocine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Effects of Pentazocine Versus Lorazepam or Placebo on Manic Symptoms |
Estimated Enrollment: | 20 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
ativan
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Drug: pentazocine
pentazocine as Talwin NX 50mg po twice
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2: Placebo Comparator
placebo
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Drug: pentazocine
pentazocine as Talwin NX 50mg po twice
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Dysregulation of the opioid system may underlie the pathophysiology of mood disorders, such as bipolar disorder. Drugs that modulate the opioid system might be effective treatments for bipolar disorder. The profile and actions of the kappa-opioid system make drugs that target this system particularly promising as a treatment modality, with relatively low risk of addictive properties. Pentazocine is an approved drug for pain relief with a good side effect profile. It is predominantly a kappa opioid agonist with weaker side effects at mu opioid receptors, at which it is an antagonist. Data from our open-label pilot study of pentazocine had promising results. We will follow up on these findings with a double-blind, placebo, and active-control study of individuals with bipolar disorder or schizoaffective disorder who are currently hospitalized with acute mania. The antimanic effects of pentazocine will be compared with a placebo control at one site, and with an active control (ativan)at the second site.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sue B | 617-855-3184 |
United States, Massachusetts | |
McLean Hospital | Recruiting |
Belmont, Massachusetts, United States, 02478 | |
Contact: Jin K 617-855-2540 | |
Principal Investigator: Beth L Murphy, MD/PhD | |
Sub-Investigator: Bruce Cohen, MD, PhD | |
United States, New Jersey | |
Jersey Shore Psychiatric Associates | Recruiting |
Neptune, New Jersey, United States, 07753 | |
Contact: Peter Harris, MD, PhD |
Principal Investigator: | Beth L Murphy, MD/PhD | Mclean Hospital |
Responsible Party: | McLean Hospital ( Beth Murphy MD, PhD ) |
Study ID Numbers: | 2006-P-002344 |
Study First Received: | February 1, 2007 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00431184 History of Changes |
Health Authority: | United States: Institutional Review Board |
bipolar disorder bipolar mania schizoaffective disorder schizoaffective mania |
mania kappa opiates opiates |
Bipolar Disorder Narcotic Antagonists Adjuvants, Immunologic Anesthetics Central Nervous System Depressants Narcotics Schizophrenia Lorazepam Affective Disorders, Psychotic |
Mental Disorders Mood Disorders Psychotic Disorders Analgesics Peripheral Nervous System Agents Pentazocine Schizophrenia and Disorders with Psychotic Features Analgesics, Opioid |
Disease Bipolar Disorder Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Narcotics Pharmacologic Actions Adjuvants, Anesthesia Affective Disorders, Psychotic Pathologic Processes Mental Disorders |
Sensory System Agents Therapeutic Uses Mood Disorders Psychotic Disorders Analgesics Peripheral Nervous System Agents Pentazocine Central Nervous System Agents Schizophrenia and Disorders with Psychotic Features Analgesics, Opioid |