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| Tracking Information | |||||
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| First Received Date ICMJE | February 1, 2007 | ||||
| Last Updated Date | June 4, 2009 | ||||
| Start Date ICMJE | January 2007 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Mania Acute Rating Scale [ Time Frame: hourly-daily ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Mania Acute Rating Scale | ||||
| Change History | Complete list of historical versions of study NCT00431184 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Young Mania Rating Scale [ Time Frame: daily ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Young Mania Rating Scale | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Pentazocine Versus Lorazepam or Placebo on Manic Symptoms | ||||
| Official Title ICMJE | Effects of Pentazocine Versus Lorazepam or Placebo on Manic Symptoms | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: pentazocine | ||||
| Study Arms / Comparison Groups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | July 2010 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00431184 | ||||
| Responsible Party | Beth Murphy MD, PhD, McLean Hospital | ||||
| Study ID Numbers ICMJE | 2006-P-002344 | ||||
| Study Sponsor ICMJE | Mclean Hospital | ||||
| Collaborators ICMJE | Stanley Medical Research Institute | ||||
| Investigators ICMJE |
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| Information Provided By | Mclean Hospital | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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