Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents (TEAM)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00057681
First received: April 4, 2003
Last updated: March 27, 2013
Last verified: March 2013
Results First Received: May 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Bipolar Disorder
Interventions: Drug: Lithium carbonate
Drug: Valproate
Drug: Risperidone

  Participant Flow


  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.
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Reporting Groups
  Description
Randomized Medication - Lithium Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
Randomized Medication - Divalproex Sodium Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
Randomized Medication - Risperidone Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
Total Total of all reporting groups

Baseline Measures
    Randomized Medication - Lithium     Randomized Medication - Divalproex Sodium     Randomized Medication - Risperidone     Total  
Number of Participants  
[units: participants]
  137     139     103     379  
Age  
[units: participants]
       
<=18 years     137     139     103     379  
Between 18 and 65 years     0     0     0     0  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  9.92  ± 2.79     9.85  ± 2.37     10.99  ± 2.95     10.19  ± 2.73  
Gender  
[units: participants]
       
Female     53     70     52     175  
Male     84     69     51     204  
Region of Enrollment  
[units: participants]
       
United States     137     139     103     379  



  Outcome Measures
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1.  Primary:   Clinical Global Impressions-Bipolar Mania Improvement   [ Time Frame: Measured at Week 8 ]

2.  Secondary:   Modified Side Effects Form for Children and Adolescents   [ Time Frame: Measured at Week 8 ]

3.  Secondary:   K-SADS Mania Rating Scale   [ Time Frame: Measured at Week 8 ]


  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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