Effects of Pentazocine Versus Lorazepam or Placebo on Manic Symptoms

This study has been completed.
Stanley Medical Research Institute
Information provided by (Responsible Party):
Beth L. Murphy MD, PhD, Mclean Hospital
ClinicalTrials.gov Identifier:
First received: February 1, 2007
Last updated: April 20, 2012
Last verified: April 2012

February 1, 2007
April 20, 2012
January 2007
March 2011   (final data collection date for primary outcome measure)
Mania Acute Rating Scale [ Time Frame: hourly-daily ] [ Designated as safety issue: No ]
Mania Acute Rating Scale
Complete list of historical versions of study NCT00431184 on ClinicalTrials.gov Archive Site
Young Mania Rating Scale [ Time Frame: daily ] [ Designated as safety issue: No ]
Young Mania Rating Scale
Not Provided
Not Provided
Effects of Pentazocine Versus Lorazepam or Placebo on Manic Symptoms
Effects of Pentazocine Versus Lorazepam or Placebo on Manic Symptoms

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.

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.

Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Bipolar Disorder
  • Schizoaffective Disorder
  • Manic Disorder
  • Mania
  • Manic State
Drug: pentazocine
pentazocine as Talwin NX 50mg po twice
  • Active Comparator: 1
    Intervention: Drug: pentazocine
  • Placebo Comparator: 2
    Intervention: Drug: pentazocine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
March 2011
March 2011   (final data collection date for primary outcome measure)

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
18 Years to 65 Years
Contact information is only displayed when the study is recruiting subjects
United States
Beth L. Murphy MD, PhD, Mclean Hospital
Mclean Hospital
Stanley Medical Research Institute
Principal Investigator: Beth L Murphy, MD/PhD Mclean Hospital
Mclean Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP