Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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
Olanzapine Group	All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
Clozapine Group	All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.

Participant Flow:   Overall Study

	Olanzapine Group	Clozapine Group
STARTED	13	12
COMPLETED	12	12
NOT COMPLETED	1	0

Reporting Groups

	Description
Olanzapine Group	All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
Clozapine Group	All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.

Baseline Measures

	Olanzapine Group	Clozapine Group	Total
Number of Participants   [units: participants]	13	12	25
Age   [units: participants]
<=18 years	13	12	25
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age   [units: years] Mean ± Standard Deviation	12.8  ± 2.4	11.7  ± 2.3	12.2  ± 2.1
Gender   [units: participants]
Female	6	4	10
Male	7	8	15
Race (NIH/OMB)   [units: participants]
American Indian or Alaska Native	0	0	0
Asian	1	0	1
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	4	3	7
White	7	8	15
More than one race	1	0	1
Unknown or Not Reported	0	1	1
Region of Enrollment   [units: participants]
United States	13	12	25

1.  Primary:

Change in the Scale for the Assessment of Negative Symptoms   [ Time Frame: 8 week double-blind study period; baseline and 8 weeks ]

2.  Primary:

Change in the Clinical Global Impression Severity of Symptoms Scale   [ Time Frame: 8 week double-blind study period; baseline and 8 weeks ]

3.  Primary:

Change in the Brief Psychiatric Rating Scale-24   [ Time Frame: 8 week double-blind study period; baseline and 8 weeks ]

4.  Primary:

Change in the Scale for the Assessment of Positive Symptoms   [ Time Frame: 8 week double-blind study period; baseline and 8 weeks ]

5.  Primary:

Change in the Bunney-Hamburg Rating Scale for Psychosis   [ Time Frame: 8 week double-blind study period; baseline and 8 weeks ]

6.  Primary:

Change in Bunney-Hamburg Rating Scale for Depression   [ Time Frame: 8 week double-blind study period; baseline and 8 weeks ]

7.  Primary:

Change in Bunney-Hamburg Rating Scale for Mania   [ Time Frame: 8 week double-blind study period; baseline and 8 weeks ]

8.  Primary:

Change in the Bunney-Hamburg Rating Scale for Anxiety   [ Time Frame: 8 week double-blind study period; baseline and 8 weeks ]

9.  Other Pre-specified:

Change in Weight   [ Time Frame: 8 week double-blind study period; baseline and 8 weeks ]

10.  Other Pre-specified:

Change in Body Mass Index (BMI)   [ Time Frame: 8 week double-blind study period; baseline and 8 weeks ]

11.  Other Pre-specified:

Change in Extrapyramidal Movements as Measured by the Abnormal Involuntary Movements Scale (AIMS)   [ Time Frame: 8 week double-blind study period; baseline and 8 weeks ]

12.  Other Pre-specified:

Change in Extrapyramidal Movements as Measured by the Simpson Angus Scale Score   [ Time Frame: 8 week double-blind study period; baseline and 8 weeks ]