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Completed

NCT Number: NCT00431184

Effects of Pentazocine Versus Lorazepam 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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mania Manic Disorder Manic State Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pentazocine

Drug

see arms description

Other names: Talwin Nx

Lorazepam

Drug

see arms description

Other names: Ativan

Primary outcomes

  1. Mania Acute Rating Scale (MACS)

    Time frame: On Day 1 and Day 2, at the time of administration of intervention and 5 hours following administration of intervention

    Assessment of current mania symptoms using Mania Acute Change Scale (MACS). All 20 questions on the scale have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean MACS score totals were reported, with the total ranging from 0-80. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and higher lower intensity. The change in MACS scores from baseline and those following treatment administration were averaged. The number below represents the average mean change.

Secondary outcomes

  1. Young Mania Rating Scale (YMRS)

    Time frame: at the time of administration of intervention and 5 hours following administration of intervention

    The YMRS is used to assess manic symptoms. There are 11 questions which ask the patient to rate the severity of symptoms. Scores range from 0 to a maximum of 60. All questions are rated based on severity, with a higher score signifying increased severity. Questions 1-4, 7, and 10 are rated on a 0-4 scale. Questions 5, 6, 8, and 9 are rated on a 0-8 scale.

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Collaborators

  • Stanley Medical Research Institute

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Feb 5, 2007
Registry last updated
Mar 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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