First Episode Schizophrenia and Cannabis-Related Disorder Study

This study has been completed.

Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

Dartmouth-Hitchcock Medical Center

ClinicalTrials.gov Identifier:

NCT00573287

First received: December 12, 2007

Last updated: March 1, 2013

Last verified: March 2013

History of Changes

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 Schizophrenia 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
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Reporting Groups

	Description
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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Reporting Groups

	Description
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
Age [units: participants]
<=18 years	2	2	4
Between 18 and 65 years	5	5	10
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	22.9 ± 5.8	22.0 ± 6.4	22.4 ± 5.9
Gender [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 ]

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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 posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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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.

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
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Results Point of Contact:

Name/Title: Alan I. Green, M.D.
Organization: Geisel School of Medicine at Dartmouth
phone: 6036507549
e-mail: alan.i.green@dartmouth.edu

No publications provided

Responsible Party:	Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov 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

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