Effects of Pentazocine Versus Lorazepam on Manic Symptoms
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ClinicalTrials.gov Identifier: NCT00431184 |
Recruitment Status :
Completed
First Posted : February 5, 2007
Results First Posted : August 21, 2014
Last Update Posted : March 6, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bipolar Disorder Schizoaffective Disorder Manic Disorder Mania Manic State | Drug: Pentazocine Drug: Lorazepam | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effects of Pentazocine Versus Lorazepam on Manic Symptoms |
Study Start Date : | January 2007 |
Actual Primary Completion Date : | March 2011 |
Actual Study Completion Date : | March 2011 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 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.
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Drug: Pentazocine
see arms description
Other Name: Talwin Nx Drug: Lorazepam see arms description
Other Name: Ativan |
Active Comparator: 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.
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Drug: Pentazocine
see arms description
Other Name: Talwin Nx Drug: Lorazepam see arms description
Other Name: Ativan |
- Mania Acute Rating Scale (MACS) [ Time Frame: On Day 1 and Day 2, at the time of administration of intervention and 5 hours following administration of intervention ]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. The change in MACS scores from baseline and those following treatment administration were averaged. The number below represents the average mean change.
- Young Mania Rating Scale (YMRS) [ Time Frame: at the time of administration of intervention and 5 hours following administration of intervention ]The YMRS is used to assess manic symptoms. There are 11 questions which ask the patient to rate the severity of symptoms. Scores range from 0 to a maximum of 60. All questions are rated based on severity, with a higher score signifying increased severity. Questions 1-4, 7, and 10 are rated on a 0-4 scale. Questions 5, 6, 8, and 9 are rated on a 0-8 scale.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT00431184
United States, Massachusetts | |
McLean Hospital | |
Belmont, Massachusetts, United States, 02478 |
Principal Investigator: | Beth L Murphy, MD/PhD | Mclean Hospital |
Publications:
Responsible Party: | Beth L. Murphy MD, PhD, Principal Investigator, Mclean Hospital |
ClinicalTrials.gov Identifier: | NCT00431184 |
Other Study ID Numbers: |
2006-P-002344 |
First Posted: | February 5, 2007 Key Record Dates |
Results First Posted: | August 21, 2014 |
Last Update Posted: | March 6, 2019 |
Last Verified: | February 2019 |
bipolar disorder bipolar mania schizoaffective disorder schizoaffective mania |
mania kappa opiates opiates |
Mania Disease Bipolar Disorder Psychotic Disorders Pathologic Processes Bipolar and Related Disorders Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Pentazocine Lorazepam Anticonvulsants Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Hypnotics and Sedatives Central Nervous System Depressants Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics, Opioid Narcotics |