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Effects of Pentazocine Versus Lorazepam on Manic Symptoms

Information source: Mclean Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder; Schizoaffective Disorder; Manic Disorder; Mania; Manic State

Intervention: Pentazocine (Drug); Lorazepam (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Mclean Hospital

Official(s) and/or principal investigator(s):
Beth L Murphy, MD/PhD, Principal Investigator, Affiliation: Mclean Hospital

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.

Clinical Details

Official title: Effects of Pentazocine Versus Lorazepam on Manic Symptoms

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Mania Acute Rating Scale (MACS)

Secondary outcome: Young Mania Rating Scale (YMRS)

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, 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 an active control (ativan).

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- bipolar or schizoaffective disorder

- currently manic

- no acute medical issues

- no substance withdrawal

Exclusion Criteria:

- unable to give informed consent

- using opiates for pain management

- history of head injury, dementia, or mental retardation

- seizure disorder

- glaucoma

- unstable cardiac condition or arrhythmia

- moderate-severe pulmonary disease

- pregnancy

Locations and Contacts

McLean Hospital, Belmont, Massachusetts 02478, United States
Additional Information

McLean hospital website, with links to research.

Related 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.

Carlezon WA Jr, B├ęguin 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. 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.

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. Epub 2004 Jan 16.

Starting date: January 2007
Last updated: August 5, 2014

Page last updated: August 23, 2015

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