Trial · NCT00001656

Comparison of Clozapine vs Olanzapine in Childhood-Onset Psychotic Disorders

NCT00001656, Phase 4, Completed, National Institute of Mental Health (NIMH); results first posted 2011-04-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparison of Clozapine vs Olanzapine in Childhood-Onset Psychotic Disorders. Trials, record NCT00001656. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00001656

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Comparison of Clozapine vs Olanzapine in Childhood-Onset Psychotic Disorders
NCT number: NCT00001656
Status: Completed
Phases: Phase 4
Enrollment: 25 participants, actual
Lead sponsor: National Institute of Mental Health (NIMH)
Conditions: Childhood Schizophrenia, Psychotic Disorder, Schizophrenia
Interventions: Olanzapine, Clozapine
First posted: 1999-11-04
Last updated: 2011-04-12
Results first posted: 2011-04-12

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in the Scale for the Assessment of Negative Symptoms	8 week double-blind study period; baseline and 8 weeks	Measures change in affective flattening or blunting, alogia, avolition/apathy, anhedonia/asociality, attention; minimum score = 0; maximum score = 125; lower values are considered a better outcome
Primary	Change in the Clinical Global Impression Severity of Symptoms Scale	8 week double-blind study period; baseline and 8 weeks	Measures change in the severity of symptoms; Minimum score = 1; maximum score = 7; lower score is considered a better outcome.
Primary	Change in the Brief Psychiatric Rating Scale-24	8 week double-blind study period; baseline and 8 weeks	A 24-item scale measuring change in interpersonal behaviors, mood, psychosis, anxiety, speech, sleep, orientation and physical activity. Lowest score = 24; highest score = 168; lower score is considered a better outcome.
Primary	Change in the Scale for the Assessment of Positive Symptoms	8 week double-blind study period; baseline and 8 weeks	Measures change in hallucinations, delusions, bizarre behavior, and thought organization. Minimum score = 0; maximum score = 170; lower score is considered a better outcome.
Primary	Change in the Bunney-Hamburg Rating Scale for Psychosis	8 week double-blind study period; baseline and 8 weeks	Measures change in psychosis severity; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.
Primary	Change in Bunney-Hamburg Rating Scale for Depression	8 week double-blind study period; baseline and 8 weeks	Measures change in severity of depression; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.
Primary	Change in Bunney-Hamburg Rating Scale for Mania	8 week double-blind study period; baseline and 8 weeks	Measures change in the severity of mania; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.
Primary	Change in the Bunney-Hamburg Rating Scale for Anxiety	8 week double-blind study period; baseline and 8 weeks	Measures change in the severity of anxiety; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.
Other	Change in Weight	8 week double-blind study period; baseline and 8 weeks
Other	Change in Body Mass Index (BMI)	8 week double-blind study period; baseline and 8 weeks	BMI is calculated by the following formula: weight (in kilograms) divided by the square of the height (in meters)

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change in the Scale for the Assessment of Negative Symptoms	8 week double-blind study period; baseline and 8 weeks	Scores on a scale	MEAN
PRIMARY	Change in the Clinical Global Impression Severity of Symptoms Scale	8 week double-blind study period; baseline and 8 weeks	Scores on a scale	MEAN
PRIMARY	Change in the Brief Psychiatric Rating Scale-24	8 week double-blind study period; baseline and 8 weeks	Scores on a scale	MEAN
PRIMARY	Change in the Scale for the Assessment of Positive Symptoms	8 week double-blind study period; baseline and 8 weeks	Scores on a scale	MEAN
PRIMARY	Change in the Bunney-Hamburg Rating Scale for Psychosis	8 week double-blind study period; baseline and 8 weeks	Scores on a scale	MEAN
PRIMARY	Change in Bunney-Hamburg Rating Scale for Depression	8 week double-blind study period; baseline and 8 weeks	Scores on a scale	MEAN
PRIMARY	Change in Bunney-Hamburg Rating Scale for Mania	8 week double-blind study period; baseline and 8 weeks	Scores on a scale	MEAN
PRIMARY	Change in the Bunney-Hamburg Rating Scale for Anxiety	8 week double-blind study period; baseline and 8 weeks	Scores on a scale	MEAN
OTHER_PRE_SPECIFIED	Change in Weight	8 week double-blind study period; baseline and 8 weeks	kilograms	MEAN
OTHER_PRE_SPECIFIED	Change in Body Mass Index (BMI)	8 week double-blind study period; baseline and 8 weeks	kg/m²	MEAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in the Scale for the Assessment of Negative Symptoms	Olanzapine Group	-14	95% Confidence Interval -20 to -7	Scores on a scale
Change in the Scale for the Assessment of Negative Symptoms	Clozapine Group	-25	95% Confidence Interval -34 to -15	Scores on a scale
Change in the Clinical Global Impression Severity of Symptoms Scale	Olanzapine Group	-0.6	95% Confidence Interval -1.3 to 0.1	Scores on a scale
Change in the Clinical Global Impression Severity of Symptoms Scale	Clozapine Group	-1.6	95% Confidence Interval -2.3 to -0.8	Scores on a scale
Change in the Brief Psychiatric Rating Scale-24	Olanzapine Group	-13	95% Confidence Interval -21 to -6	Scores on a scale
Change in the Brief Psychiatric Rating Scale-24	Clozapine Group	-19	95% Confidence Interval -26 to -12	Scores on a scale
Change in the Scale for the Assessment of Positive Symptoms	Olanzapine Group	-7	95% Confidence Interval -18 to 5	Scores on a scale
Change in the Scale for the Assessment of Positive Symptoms	Clozapine Group	-21	95% Confidence Interval -33 to -9	Scores on a scale
Change in the Bunney-Hamburg Rating Scale for Psychosis	Olanzapine Group	-3.1	95% Confidence Interval -5.0 to -1.2	Scores on a scale
Change in the Bunney-Hamburg Rating Scale for Psychosis	Clozapine Group	-4	95% Confidence Interval -5.3 to -2.7	Scores on a scale

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Olanzapine Group	13
Overall Study	STARTED	Clozapine Group	12
Overall Study	COMPLETED	Olanzapine Group	12
Overall Study	COMPLETED	Clozapine Group	12
Overall Study	NOT COMPLETED	Olanzapine Group	1
Overall Study	NOT COMPLETED	Clozapine Group	0

Source ClinicalTrials.gov

Adverse events22

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Enuresis	Renal and urinary disorders	Olanzapine Group	1	13	1
other	Enuresis	Renal and urinary disorders	Clozapine Group	5	12	5
other	Increased appetite	Metabolism and nutrition disorders	Olanzapine Group	4	13	4
other	Increased appetite	Metabolism and nutrition disorders	Clozapine Group	4	12	4
other	Hypersalivation	Gastrointestinal disorders	Olanzapine Group	4	13	4
other	Hypersalivation	Gastrointestinal disorders	Clozapine Group	8	12	8
other	Constipation	Gastrointestinal disorders	Olanzapine Group	2	13	2
other	Constipation	Gastrointestinal disorders	Clozapine Group	2	12	2
other	Difficulty concentrating	Nervous system disorders	Olanzapine Group	1	13	1
other	Difficulty concentrating	Nervous system disorders	Clozapine Group	4	12	4

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Olanzapine Group
Total, all-cause mortality	Clozapine Group
Total, other adverse events	Olanzapine Group	13	13
Total, other adverse events	Clozapine Group	12	12
Total, serious adverse events	Olanzapine Group	1	13
Total, serious adverse events	Clozapine Group	2	12

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
7701277	BACKGROUND	PubMed
10578456	BACKGROUND	PubMed
16818861	RESULT	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Olanzapine Group vs Clozapine Group: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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