Phase 2 Completed N=19 Randomized Quadruple-blind Treatment

Effects of Pentazocine Versus Lorazepam on Manic Symptoms

Bipolar Disorder · schizoaffective disorder · Manic Disorder · Mania

Source: ClinicalTrials.gov NCT00431184 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcomePrimary: Mania Acute Rating Scale (MACS) — 3.9; 6.4 units on a scale — p=0.22

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mania Acute Rating Scale (MACS)	3.9; 6.4	0.22
SECONDARY Young Mania Rating Scale (YMRS)	23.0; 22.6	0.83

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00431184). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.