Effects of Pentazocine Versus Lorazepam on Manic Symptoms
1 other identifier
interventional
19
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2007
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 1, 2007
CompletedFirst Posted
Study publicly available on registry
February 5, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
August 21, 2014
CompletedMarch 6, 2019
February 1, 2019
4.2 years
February 1, 2007
June 19, 2014
February 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mania Acute Rating Scale (MACS)
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.
On Day 1 and Day 2, at the time of administration of intervention and 5 hours following administration of intervention
Secondary Outcomes (1)
Young Mania Rating Scale (YMRS)
at the time of administration of intervention and 5 hours following administration of intervention
Study Arms (2)
Pentazocine then Lorazepam
ACTIVE COMPARATORIn 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.
Lorazepam then Pentazocine
ACTIVE COMPARATORIn 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.
Interventions
see arms description
see arms description
Eligibility Criteria
You may qualify if:
- bipolar or schizoaffective disorder
- currently manic
- no acute medical issues
- no substance withdrawal
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mclean Hospitallead
- Stanley Medical Research Institutecollaborator
Study Sites (1)
McLean Hospital
Belmont, Massachusetts, 02478, United States
Related Publications (4)
Ma J, Ye N, Lange N, Cohen BM. Dynorphinergic GABA neurons are a target of both typical and atypical antipsychotic drugs in the nucleus accumbens shell, central amygdaloid nucleus and thalamic central medial nucleus. Neuroscience. 2003;121(4):991-8. doi: 10.1016/s0306-4522(03)00397-x.
PMID: 14580949BACKGROUNDCarlezon WA Jr, Beguin C, DiNieri JA, Baumann MH, Richards MR, Todtenkopf MS, Rothman RB, Ma Z, Lee DY, Cohen BM. Depressive-like effects of the kappa-opioid receptor agonist salvinorin A on behavior and neurochemistry in rats. J Pharmacol Exp Ther. 2006 Jan;316(1):440-7. doi: 10.1124/jpet.105.092304. Epub 2005 Oct 13.
PMID: 16223871BACKGROUNDMague SD, Pliakas AM, Todtenkopf MS, Tomasiewicz HC, Zhang Y, Stevens WC Jr, Jones RM, Portoghese PS, Carlezon WA Jr. Antidepressant-like effects of kappa-opioid receptor antagonists in the forced swim test in rats. J Pharmacol Exp Ther. 2003 Apr;305(1):323-30. doi: 10.1124/jpet.102.046433.
PMID: 12649385BACKGROUNDTodtenkopf MS, Marcus JF, Portoghese PS, Carlezon WA Jr. Effects of kappa-opioid receptor ligands on intracranial self-stimulation in rats. Psychopharmacology (Berl). 2004 Apr;172(4):463-70. doi: 10.1007/s00213-003-1680-y. Epub 2004 Jan 16.
PMID: 14727002BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Beth Murphy MD
- Organization
- McLean Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Beth L Murphy, MD/PhD
Mclean Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 1, 2007
First Posted
February 5, 2007
Study Start
January 1, 2007
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
March 6, 2019
Results First Posted
August 21, 2014
Record last verified: 2019-02