Effects of Pentazocine 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:
NCT00125931
First received: August 1, 2005
Last updated: August 25, 2014
Last verified: August 2014
Results First Received: October 22, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Bipolar Disorder
Intervention: Drug: Talwin Nx

  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
Subjects were 18-60 year old male and female individuals who were currently hospitalized.

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
Treatment Group Open label group with pentazocine treatment.

Participant Flow:   Overall Study
    Treatment Group  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     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.
Inpatients with manic symptoms.

Reporting Groups
  Description
Open Label Open label treatment with pentazocine

Baseline Measures
    Open Label  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     10  
>=65 years     0  
Gender  
[units: participants]
 
Female     3  
Male     7  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   YMRS Scores   [ Time Frame: Each morning of the three-day study ]


  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
Small number of participants in open-label trial.


  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 PhD
Organization: McLean Hospital
phone: 617-855-2297
e-mail: BMurphy5@partners.org


Publications of Results:
Other Publications:

Responsible Party: Beth L. Murphy MD, PhD, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00125931     History of Changes
Other Study ID Numbers: 2005P-001260
Study First Received: August 1, 2005
Results First Received: October 22, 2012
Last Updated: August 25, 2014
Health Authority: United States: Institutional Review Board