Effects of Pentazocine on Manic Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00125931
Recruitment Status : Completed
First Posted : August 2, 2005
Results First Posted : September 4, 2014
Last Update Posted : September 4, 2014
Stanley Medical Research Institute
Information provided by (Responsible Party):
Beth L. Murphy MD, PhD, Mclean Hospital

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Bipolar Disorder
Intervention: Drug: Talwin Nx

  Participant Flow

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
Treatment Group Open label group with pentazocine treatment.

Participant Flow:   Overall Study
    Treatment Group

  Baseline Characteristics

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
Open Label Open label treatment with pentazocine

Baseline Measures
   Open Label 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   10 
>=65 years   0 
[Units: Participants]
Female   3 
Male   7 

  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

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

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

Publications of Results:
Other Publications:

Responsible Party: Beth L. Murphy MD, PhD, Mclean Hospital Identifier: NCT00125931     History of Changes
Other Study ID Numbers: 2005P-001260
First Submitted: August 1, 2005
First Posted: August 2, 2005
Results First Submitted: October 22, 2012
Results First Posted: September 4, 2014
Last Update Posted: September 4, 2014