Effects of Pentazocine Versus Lorazepam on Manic Symptoms

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Beth L. Murphy MD, PhD, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00431184
First received: February 1, 2007
Last updated: August 5, 2014
Last verified: August 2014
Results First Received: June 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Bipolar Disorder
Schizoaffective Disorder
Manic Disorder
Mania
Manic State
Interventions: Drug: Pentazocine
Drug: Lorazepam

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
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.

Participant Flow for 2 periods

Period 1:   1st Intervention (Day 1)
    Pentazocine Then Lorazepam     Lorazepam Then Pentazocine  
STARTED     10     9  
COMPLETED     10     9  
NOT COMPLETED     0     0  

Period 2:   Second Intervention (Day 2)
    Pentazocine Then Lorazepam     Lorazepam Then Pentazocine  
STARTED     10     9  
COMPLETED     10     9  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
    Pentazocine Then Lorazepam     Lorazepam Then Pentazocine     Total  
Number of Participants  
[units: participants]
  10     9     19  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     9     19  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     6     6     12  
Male     4     3     7  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Young Mania Rating Scale (YMRS)   [ Time Frame: at the time of administration of intervention and 5 hours following administration of intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Beth Murphy MD
Organization: McLean Hospital
phone: 617-855-2297
e-mail: BMurphy5@partners.org


Publications:

Responsible Party: Beth L. Murphy MD, PhD, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00431184     History of Changes
Other Study ID Numbers: 2006-P-002344
Study First Received: February 1, 2007
Results First Received: June 19, 2014
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board