Phase 2
Completed N=10
Effects of Pentazocine on Manic Symptoms
Source: ClinicalTrials.gov NCT00125931 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Mania Symptoms Using MACS — 18.6; 11.0 units on a scale — p=0.01
Summary
The opiate neurotransmitter system is thought to be involved in many abnormal mood states. Some researchers have suggested that changes in this system may trigger the switch to/from manic and depressive states in bipolar disorder. One problem with most of the currently available opiate medications is that they can produce addiction/dependence. A particular kind of opiate medication known as kappa-opiates may be able to produce changes in this system with much less risk of addiction. This study looks at Talwin (a combination of pentazocine and naloxone), a medication which affects the kappa and mu opiate systems. The study will examine whether two doses of Talwin affect manic symptoms in people who have been admitted to the hospital. This study will give more information about the involvement of the opiate system in bipolar disorder, and give important information for use in developing new treatments.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mania Symptoms Using MACS |
18.6; 11.0 | 0.01 sig |
| SECONDARY YMRS Scores |
23.6; 22.0; 12.7 | 0.01 sig |
Eligibility Criteria
Inclusion Criteria
- Young Mania Rating Scale (YMRS) greater than 14
- Inpatient
Exclusion Criteria
- History of opiate abuse/dependence
- Recent history of substance abuse
- Pregnancy
- Unstable medical issues
- Use of opiate medications for pain management
Data sourced from ClinicalTrials.gov (NCT00125931). 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.