Effects of Pentazocine Versus Lorazepam on Manic Symptoms

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Manic Disorder; Manic State; Bipolar Disorder; Schizoaffective Disorder; Mania

Treatments: Drug: Pentazocine; Drug: Lorazepam

Study type: Interventional

Funder types: Other

Identifiers

NCT00431184

2006-P-002344

Details and patient eligibility

About

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.

Full 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).

Enrollment: 19 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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19 participants in 2 patient groups

Pentazocine then Lorazepam

Active Comparator group

Description:

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.

Treatment:

Drug: Lorazepam

Drug: Pentazocine

Lorazepam then Pentazocine

Active Comparator group

Description:

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.

Treatment:

Drug: Lorazepam

Drug: Pentazocine