Trial · NCT00401973

Assessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine

NCT00401973, Phase 3, Completed, Eli Lilly and Company; results first posted 2009-09-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Assessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine. Trials, record NCT00401973. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00401973

On this page

Trial

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

Title: Assessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine
NCT number: NCT00401973
Status: Completed
Phases: Phase 3
Enrollment: 199 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Schizophrenia, Schizoaffective Disorders
Interventions: olanzapine, amantadine, metformin, zonisamide, Wellness education
First posted: 2006-11-22
Last updated: 2009-10-06
Results first posted: 2009-09-30

Source ClinicalTrials.gov

Registered outcomes11

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

List	Outcome	Time frame	Description
Primary	Change From Baseline to Endpoint in Weight	Baseline to endpoint (22 weeks)
Secondary	Mean Change From Baseline to Endpoint in Fasting Triglycerides	Baseline to endpoint (22 weeks)
Secondary	Mean Change From Baseline to Endpoint in Fasting Total Cholesterol	Baseline to endpoint (22 weeks)
Secondary	Mean Change From Baseline to Endpoint in Fasting High Density Lipoprotein (HDL) Cholesterol	Baseline to endpoint (22 weeks)
Secondary	Mean Change From Baseline to Endpoint in Fasting Low Density Lipoprotein (LDL) Cholesterol	Baseline to endpoint (22 weeks)
Secondary	Mean Change From Baseline to Endpoint in Fasting Glucose	Baseline to endpoint (22 weeks)
Secondary	Mean Change From Baseline to Endpoint in Hemoglobin A1c	Baseline to endpoint (22 weeks)
Secondary	Change From Baseline to Endpoint in Brief Psychiatric Rating Scale (BPRS) Total Score	Baseline to endpoint (22 weeks)	The BPRS is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. Each item is rated on a scale from 1 (symptom not present) to 7 (symptom extremely severe). The BPRS total score ranges from 18 to 126.
Secondary	Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	Baseline to endpoint (22 weeks)	The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Secondary	Change From Baseline to Endpoint in Clinical Global Impression - Severity Scale (CGI-S)	Baseline to endpoint (22 weeks)	Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Endpoint in Weight	Baseline to endpoint (22 weeks)	All randomized participants with baseline and at least one postbaseline measurement.	kilograms	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline to Endpoint in Fasting Triglycerides	Baseline to endpoint (22 weeks)	All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.	millimoles per Liter (mmol/L)	MEAN
SECONDARY	Mean Change From Baseline to Endpoint in Fasting Total Cholesterol	Baseline to endpoint (22 weeks)	All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.	millimole per Liter (mmol/L)	MEAN
SECONDARY	Mean Change From Baseline to Endpoint in Fasting High Density Lipoprotein (HDL) Cholesterol	Baseline to endpoint (22 weeks)	Number of randomized participants with a baseline and at least one post-baseline measurement. Last post-baseline measurement carried forward.	millimole per liter (mmol/L)	MEAN
SECONDARY	Mean Change From Baseline to Endpoint in Fasting Low Density Lipoprotein (LDL) Cholesterol	Baseline to endpoint (22 weeks)	All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.	millimole per Liter (mmol/L)	MEAN
SECONDARY	Mean Change From Baseline to Endpoint in Fasting Glucose	Baseline to endpoint (22 weeks)	All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.	millimole per Liter (mmol/L)	MEAN
SECONDARY	Mean Change From Baseline to Endpoint in Hemoglobin A1c	Baseline to endpoint (22 weeks)	All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.	percent hemoglobin A1c	MEAN
SECONDARY	Change From Baseline to Endpoint in Brief Psychiatric Rating Scale (BPRS) Total Score	Baseline to endpoint (22 weeks)	Number of participants with a baseline and at least one post baseline measurement. Last post-baseline measurement carried forward.	units on a scale	MEAN
SECONDARY	Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	Baseline to endpoint (22 weeks)	Number of participants with a baseline and at least one post baseline measurement. Last post-baseline measurement carried forward.	units on a scale	MEAN
SECONDARY	Change From Baseline to Endpoint in Clinical Global Impression - Severity Scale (CGI-S)	Baseline to endpoint (22 weeks)	Number of participants with a baseline and at least one post baseline measurement. Last post-baseline measurement carried forward.	units on a scale	MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group73

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline to Endpoint in Weight	Olanzapine		2.76	Standard Error 0.75	kilograms
Change From Baseline to Endpoint in Weight	Olanzapine + Amantadine		2.40	Standard Error 0.65	kilograms
Change From Baseline to Endpoint in Weight	Olanzapine + Metformin		0.65	Standard Error 0.63	kilograms
Mean Change From Baseline to Endpoint in Fasting Triglycerides	Olanzapine	Baseline	1.58	Standard Deviation 0.81	millimoles per Liter (mmol/L)
Mean Change From Baseline to Endpoint in Fasting Triglycerides	Olanzapine + Amantadine	Baseline	1.61	Standard Deviation 0.76	millimoles per Liter (mmol/L)
Mean Change From Baseline to Endpoint in Fasting Triglycerides	Olanzapine + Metformin	Baseline	1.68	Standard Deviation 1.00	millimoles per Liter (mmol/L)
Mean Change From Baseline to Endpoint in Fasting Triglycerides	Olanzapine	Change from Baseline	0.33	Standard Deviation 1.01	millimoles per Liter (mmol/L)
Mean Change From Baseline to Endpoint in Fasting Triglycerides	Olanzapine + Amantadine	Change from Baseline	0.35	Standard Deviation 0.88	millimoles per Liter (mmol/L)
Mean Change From Baseline to Endpoint in Fasting Triglycerides	Olanzapine + Metformin	Change from Baseline	0.06	Standard Deviation 0.64	millimoles per Liter (mmol/L)
Mean Change From Baseline to Endpoint in Fasting Total Cholesterol	Olanzapine	Baseline	5.01	Standard Deviation 1.00	millimole per Liter (mmol/L)

1 to 10 of 73Source ClinicalTrials.gov

See all 73 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Olanzapine	50
Overall Study	STARTED	Olanzapine + Amantadine	76
Overall Study	STARTED	Olanzapine + Metformin	73
Overall Study	COMPLETED	Olanzapine	39
Overall Study	COMPLETED	Olanzapine + Amantadine	50
Overall Study	COMPLETED	Olanzapine + Metformin	50
Overall Study	NOT COMPLETED	Olanzapine	11
Overall Study	NOT COMPLETED	Olanzapine + Amantadine	26
Overall Study	NOT COMPLETED	Olanzapine + Metformin	23

Source ClinicalTrials.gov

Adverse events87

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	Constipation	Gastrointestinal disorders	Olanzapine	0	50	0
other	Constipation	Gastrointestinal disorders	Olanzapine + Amantadine	3	76	3
other	Constipation	Gastrointestinal disorders	Olanzapine + Metformin	3	73	3
other	Diarrhoea	Gastrointestinal disorders	Olanzapine	0	50	0
other	Diarrhoea	Gastrointestinal disorders	Olanzapine + Amantadine	3	76	3
other	Diarrhoea	Gastrointestinal disorders	Olanzapine + Metformin	10	73	11
other	Dry mouth	Gastrointestinal disorders	Olanzapine	2	50	2
other	Dry mouth	Gastrointestinal disorders	Olanzapine + Amantadine	4	76	4
other	Dry mouth	Gastrointestinal disorders	Olanzapine + Metformin	0	73	0
other	Nausea	Gastrointestinal disorders	Olanzapine	2	50	2

1 to 10 of 87Source ClinicalTrials.gov

See all 87 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected
Total, all-cause mortality	Olanzapine
Total, all-cause mortality	Olanzapine + Amantadine
Total, all-cause mortality	Olanzapine + Metformin
Total, other adverse events	Olanzapine	26
Total, other adverse events	Olanzapine + Amantadine	38
Total, other adverse events	Olanzapine + Metformin	46
Total, serious adverse events	Olanzapine	5
Total, serious adverse events	Olanzapine + Amantadine	4
Total, serious adverse events	Olanzapine + Metformin	4

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
20840778	DERIVED	PubMed
21672497	DERIVED	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 comparisons0

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

None in this release.

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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GET https://conductscience.org/api/trials/v1/NCT00401973/results?page=2

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