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Effectiveness of Tropisetron Plus Risperidone for Improving Cognitive and Perceptual Disturbances in Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Thomas R. Kosten, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00435370
First received: February 13, 2007
Last updated: February 4, 2017
Last verified: February 2017
Results First Received: August 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Conditions: Smoking Cessation
Schizophrenia
Interventions: Drug: Tropisetron
Drug: Placebo
Drug: Risperidone

  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
The recruitment period began in May 2006 and ended in April 2011. Participants were approached for participation in this study after being hospitalized for at least 2 weeks if they were schizophrenic and capable of providing written informed consent.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After signing informed consent for participation in the study, subjects were interviewed by study doctor and all medical and psychiatric data were reviewed prior to admitting the subject and beginning medication.

Reporting Groups
  Description
Tropisetron Tropisetron (10mg/day) + risperidone(6mg/day)
Placebo Placebo + risperidone (6mg/day)

Participant Flow:   Overall Study
    Tropisetron   Placebo
STARTED   90   89 [1] 
COMPLETED   68   69 [2] 
NOT COMPLETED   22   20 
Adverse Event                8                8 
Withdrawal by Subject                10                10 
Antipsychotic medication changed                4                2 
[1] The recruitment restarted in August, 2010.
[2] The entire recruitment has been completed in December, 2011.



  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
Tropisetron Tropisetron (10mg/day) + risperidone(6mg/day)
Placebo Placebo + risperidone (6mg/day)
Total Total of all reporting groups

Baseline Measures
   Tropisetron   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 90   89   179 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      90 100.0%      89 100.0%      179 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 28.8  (9.2)   28.3  (9.9)   28.6  (9.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      52  57.8%      50  56.2%      102  57.0% 
Male      38  42.2%      39  43.8%      77  43.0% 
Region of Enrollment 
[Units: Participants]
     
China   90   89   179 


  Outcome Measures

1.  Primary:   Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognition Domains   [ Time Frame: end of 12 wk treatment ]


  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
Since all participants were the first episode and drug naive patients, some participants quit before the completion of the entire clinical 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: Dr. Thomas R. Kosten
Organization: Baylor College of Medicine
phone: (713) 794-7032
e-mail: kosten@bcm.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Thomas R. Kosten, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00435370     History of Changes
Other Study ID Numbers: U01MH079639 ( US NIH Grant/Contract Award Number )
Study First Received: February 13, 2007
Results First Received: August 1, 2013
Last Updated: February 4, 2017