Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

First Episode Schizophrenia and Cannabis-Related Disorder Study

This study has been completed.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center Identifier:
First received: December 12, 2007
Last updated: March 1, 2013
Last verified: March 2013
Results First Received: January 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Cannabis-Related Disorder
Substance-Related Disorders
Psychotic Disorders
Interventions: Drug: clozapine
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
Recruitment was conducted through Dartmouth Hitchcock Medical Center, the state psychiatric hospital, local community mental health centers and mailing to schools and primary care providers.

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

Reporting Groups
Clozapine clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
Risperidone risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks

Participant Flow:   Overall Study
    Clozapine     Risperidone  
STARTED     7     7  
COMPLETED     3     4  
NOT COMPLETED     4     3  

  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
Clozapine clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
Risperidone risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
Total Total of all reporting groups

Baseline Measures
    Clozapine     Risperidone     Total  
Number of Participants  
[units: participants]
  7     7     14  
[units: participants]
<=18 years     2     2     4  
Between 18 and 65 years     5     5     10  
>=65 years     0     0     0  
[units: years]
Mean ± Standard Deviation
  22.9  ± 5.8     22.0  ± 6.4     22.4  ± 5.9  
[units: participants]
Female     4     2     6  
Male     3     5     8  
Region of Enrollment  
[units: participants]
United States     7     7     14  

  Outcome Measures

1.  Primary:   Number of Participants Demonstrating Improvement in Substance Use   [ Time Frame: 24 weeks ]

2.  Secondary:   Psychiatric Symptoms Measured Using the Brief Psychiatric Rating Scale, Clinical Global Inventory, and Schedule for the Assessment of Negative Symptoms at Baseline and Then at Weeks 4, 8, 12, 16, 20, and 24.   [ Time Frame: 24 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

  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
No text entered.

  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: Alan I. Green, M.D.
Organization: Geisel School of Medicine at Dartmouth
phone: 6036507549

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT00573287     History of Changes
Obsolete Identifiers: NCT00063349
Other Study ID Numbers: MG 62157-02, MG 62157-02
Study First Received: December 12, 2007
Results First Received: January 16, 2013
Last Updated: March 1, 2013
Health Authority: United States: Institutional Review Board