Effects of Pentazocine Versus Lorazepam or Placebo on Manic Symptoms - Full Text View

Sponsor:	Mclean Hospital
Collaborator:	Stanley Medical Research Institute
Information provided by:	Mclean Hospital
ClinicalTrials.gov Identifier:	NCT00431184

Purpose

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
Bipolar Disorder Schizoaffective Disorder Manic Disorder Mania Manic State	Drug: pentazocine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effects of Pentazocine Versus Lorazepam or Placebo on Manic Symptoms

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Pentazocine lactate Pentazocine hydrochloride Talwin Nx Pentazocine Lorazepam

U.S. FDA Resources

Further study details as provided by Mclean Hospital:

Primary Outcome Measures:

Mania Acute Rating Scale [ Time Frame: hourly-daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Young Mania Rating Scale [ Time Frame: daily ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	January 2007
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 ativan	Drug: pentazocine pentazocine as Talwin NX 50mg po twice
Placebo Comparator: 2 placebo	Drug: pentazocine pentazocine as Talwin NX 50mg po twice

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431184

Locations

United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
United States, New Jersey
Jersey Shore Psychiatric Associates
Neptune, New Jersey, United States, 07753

Sponsors and Collaborators

Mclean Hospital

Stanley Medical Research Institute

Investigators

Principal Investigator:

Beth L Murphy, MD/PhD

Mclean Hospital

More Information

Additional Information:

McLean hospital website, with links to research. This link exits the ClinicalTrials.gov site

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, 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. 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.

Responsible Party:	Beth Murphy MD, PhD, McLean Hospital
ClinicalTrials.gov Identifier:	NCT00431184 History of Changes
Other Study ID Numbers:	2006-P-002344
Study First Received:	February 1, 2007
Last Updated:	February 8, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Mclean Hospital:

bipolar disorder
bipolar mania
schizoaffective disorder
schizoaffective mania

mania
kappa opiates
opiates

Additional relevant MeSH terms:

Bipolar Disorder
Psychotic Disorders
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Lorazepam
Pentazocine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs

Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Analgesics, Opioid
Analgesics
Sensory System Agents
Adjuvants, Anesthesia

ClinicalTrials.gov processed this record on February 12, 2012