Effects of Pentazocine on Manic Symptoms
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ClinicalTrials.gov Identifier: NCT00125931 |
Recruitment Status :
Completed
First Posted : August 2, 2005
Results First Posted : September 4, 2014
Last Update Posted : September 4, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bipolar Disorder | Drug: Talwin Nx | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Inpatient Clinical Trial Examining the Effects of Pentazocine on Manic Symptoms |
Study Start Date : | September 2005 |
Actual Primary Completion Date : | August 2008 |
Actual Study Completion Date : | December 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: Pentazocine/Talwin
Talwin NX
|
Drug: Talwin Nx
Talwin NX 50mg po twice
Other Name: Pentazocine |
- Mania Symptoms Using MACS [ Time Frame: hourly for 6 hours after first dose of pentazocine; hour 0 is the baseline score and also when first dose of pentazocine was administered ]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.
- YMRS Scores [ Time Frame: Each morning of the three-day study ]Assessment of current mania symptoms using YMRS. All questions have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean YMRS scores were reported, with the total ranging from 0-44. 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.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125931
Principal Investigator: | Beth L Murphy, MD, PhD | Mclean Hospital |
Publications of Results:
Other Publications:
Responsible Party: | Beth L. Murphy MD, PhD, Principal Investigator, Mclean Hospital |
ClinicalTrials.gov Identifier: | NCT00125931 |
Other Study ID Numbers: |
2005P-001260 |
First Posted: | August 2, 2005 Key Record Dates |
Results First Posted: | September 4, 2014 |
Last Update Posted: | September 4, 2014 |
Last Verified: | August 2014 |
bipolar disorder mania manic state opiate kappa |
Bipolar Disorder Bipolar and Related Disorders Mental Disorders Pentazocine Analgesics, Opioid Narcotics Central Nervous System Depressants |
Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Narcotic Antagonists |