Effects of Pentazocine Versus Lorazepam on Manic Symptoms

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2011-03-31

Brief Summary

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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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Detailed Description

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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).

Conditions

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Bipolar Disorder Schizoaffective Disorder Manic Disorder Mania Manic State

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Pentazocine

Intervention Type DRUG

see arms description

Lorazepam

Intervention Type DRUG

see arms description

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.

Group Type ACTIVE_COMPARATOR

Pentazocine

Intervention Type DRUG

see arms description

Lorazepam

Intervention Type DRUG

see arms description

Interventions

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Pentazocine

see arms description

Intervention Type DRUG

Lorazepam

see arms description

Intervention Type DRUG

Other Intervention Names

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Talwin Nx Ativan

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No