Effects of Pentazocine Versus Lorazepam on Manic Symptoms

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Beth L. Murphy MD, PhD, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00431184
First received: February 1, 2007
Last updated: August 5, 2014
Last verified: August 2014

February 1, 2007
August 5, 2014
January 2007
March 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Mania Acute Rating Scale
Complete list of historical versions of study NCT00431184 on ClinicalTrials.gov Archive Site
Young Mania Rating Scale (YMRS) [ Time Frame: at the time of administration of intervention and 5 hours following administration of intervention ] [ Designated as safety issue: No ]
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.
Young Mania Rating Scale
Not Provided
Not Provided
 
Effects of Pentazocine Versus Lorazepam on Manic Symptoms
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.

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).

Interventional
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
    see arms description
    Other Name: Talwin Nx
  • Drug: Lorazepam
    see arms description
    Other Name: Ativan
  • Active Comparator: Pentazocine then Lorazepam
    In the first leg of the study, pentazocine will be given to subjects randomly assigned to this group. On Day 1, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later. On Day 2, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later.
    Interventions:
    • Drug: Pentazocine
    • Drug: Lorazepam
  • Active Comparator: Lorazepam then Pentazocine
    In the first leg of the study, lorazepam will be given to subjects randomly assigned to this group. On Day 3, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later. On Day 2, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later.
    Interventions:
    • Drug: Pentazocine
    • Drug: Lorazepam

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00431184
2006-P-002344
No
Beth L. Murphy MD, PhD, Mclean Hospital
Mclean Hospital
Stanley Medical Research Institute
Principal Investigator: Beth L Murphy, MD/PhD Mclean Hospital
Mclean Hospital
August 2014

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