First Episode Schizophrenia and Cannabis-Related Disorder Study

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: NCT00573287
Recruitment Status : Completed
First Posted : December 14, 2007
Results First Posted : February 18, 2013
Last Update Posted : March 23, 2018
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Alan Green, Dartmouth-Hitchcock Medical Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Cannabis-Related Disorder
Substance-Related Disorders
Psychotic Disorders
Interventions: Drug: clozapine
Drug: risperidone

  Participant Flow

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 

  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.
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 
Overall Participants Analyzed 
[Units: Participants]
 7   7   14 
[Units: Participants]
Count of Participants
<=18 years      2  28.6%      2  28.6%      4  28.6% 
Between 18 and 65 years      5  71.4%      5  71.4%      10  71.4% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
[Units: Years]
Mean (Standard Deviation)
 22.9  (5.8)   22.0  (6.4)   22.4  (5.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      4  57.1%      2  28.6%      6  42.9% 
Male      3  42.9%      5  71.4%      8  57.1% 
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.  

  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
No text entered.

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

Responsible Party: Alan Green, Dartmouth-Hitchcock Medical Center Identifier: NCT00573287     History of Changes
Obsolete Identifiers: NCT00063349
Other Study ID Numbers: MG 62157-02
MG 62157-02 ( Other Identifier: NIMH )
First Submitted: December 12, 2007
First Posted: December 14, 2007
Results First Submitted: January 16, 2013
Results First Posted: February 18, 2013
Last Update Posted: March 23, 2018