Trial · NCT00709202

Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain

NCT00709202, Phase 2, Completed, Nathan Kline Institute for Psychiatric Research; results first posted 2019-01-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain. Trials, record NCT00709202. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00709202

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Trial

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

Title: Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain
NCT number: NCT00709202
Status: Completed
Phases: Phase 2
Enrollment: 48 participants, actual
Lead sponsor: Nathan Kline Institute for Psychiatric Research
Conditions: Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Bipolar I Disorder, Bipolar II, Bipolar NOS(Not Otherwise Specified), Psychotic Disorder Not Otherwise Specified, Autism Spectrum Disorder
Interventions: Betahistine, Placebo Oral Tablet
First posted: 2008-07-03
Last updated: 2019-01-25
Results first posted: 2019-01-25

Source ClinicalTrials.gov

Registered outcomes11

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

List	Outcome	Time frame	Description
Primary	Change in Weight	Measured at each visit from baseline to end of study over a 12 week period	Least Squares estimated change in weight from end of study minus baseline
Secondary	Change in Body Mass Index (BMI)	Measured at each visit from baseline to end of study over a 12 week period.	Least Squares estimated change in BMI from end of study minus baseline
Secondary	Change in Waist Circumference	Measured at each visit from baseline to end of study over a 12 week period.	Least Squares estimated change in waist circumference from end of study minus baseline
Secondary	Change in Hip Circumference	Measured at each visit from baseline to end of study over a 12 week period.	Least Squares estimated change in hip circumference from end of study minus baseline
Secondary	Change in Glucose	Measured at each visit from baseline to end of study over a 12 week period.	Least Squares estimated change in glucose from end of study minus baseline
Secondary	Change in Cholesterol	Measured at each visit from baseline to end of study over a 12 week period.	Least Squares estimated change in cholesterol from end of study minus baseline
Secondary	Change in LDL	Measured at each visit from baseline to end of study over a 12 week period.	Least Squares estimated change in LDL from end of study minus baseline
Secondary	Change in HDL	Measured at each visit from baseline to end of study over a 12 week period.	Least Squares estimated change in HDL from end of study minus baseline
Secondary	Change in Triglycerides	Measured at each visit from baseline to end of study over a 12 week period.	Least Squares estimated change in triglycerides from end of study minus baseline
Secondary	Change in Appetite Hunger	Measured at baseline and 12 weeks	Least Squares estimated change in appetite hunger from end of study minus baseline.The scale used has no specific name. It is a Visual Analogue Scale, where a line is drawn of 10 cm long with the statement beneath the line" How Hungry do you feel '. The subject places an X on the line. The measurements, the number of centimeters from the start of the line ("O"), indicate the amount of hunger. The higher the cm number the higher the feeling of hunger. The measure reported is the difference in this scale reading in cm from after the test meal to before consuming the test meal. The number (mean, s.e.m) presented is the analysis of covariance model estimated difference score at the end of study, with the covariate of the same score at baseline.

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 in Weight	Measured at each visit from baseline to end of study over a 12 week period	Least Squares estimated change in weight from end of study minus baseline for all subjects who had at least one post-baseline weight evaluation, using mixed model analysis.	kg. (killograms)	LEAST_SQUARES_MEAN
SECONDARY	Change in Body Mass Index (BMI)	Measured at each visit from baseline to end of study over a 12 week period.	Least Squares estimated change in BMI from end of study minus baseline for all subjects who had at least one post-baseline weight evaluation, using mixed model analysis.	kg/m^2	LEAST_SQUARES_MEAN
SECONDARY	Change in Waist Circumference	Measured at each visit from baseline to end of study over a 12 week period.		centimeters	LEAST_SQUARES_MEAN
SECONDARY	Change in Hip Circumference	Measured at each visit from baseline to end of study over a 12 week period.		centimeters	LEAST_SQUARES_MEAN
SECONDARY	Change in Glucose	Measured at each visit from baseline to end of study over a 12 week period.		mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Change in Cholesterol	Measured at each visit from baseline to end of study over a 12 week period.		mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Change in LDL	Measured at each visit from baseline to end of study over a 12 week period.		mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Change in HDL	Measured at each visit from baseline to end of study over a 12 week period.		mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Change in Triglycerides	Measured at each visit from baseline to end of study over a 12 week period.		mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Change in Appetite Hunger	Measured at baseline and 12 weeks		units on a scale	LEAST_SQUARES_MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group22

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

Outcome	Group	Value	Spread	Units
Change in Weight	Betahistine	-2.0021	Standard Error 0.7970	kg. (killograms)
Change in Weight	Placebo	-1.5490	Standard Error 0.7650	kg. (killograms)
Change in Body Mass Index (BMI)	Betahistine	-0.5524	Standard Error 0.2747	kg/m^2
Change in Body Mass Index (BMI)	Placebo	-0.5637	Standard Error 0.2653	kg/m^2
Change in Waist Circumference	Betahistine	4.0928	Standard Error 1.3884	centimeters
Change in Waist Circumference	Placebo	2.4864	Standard Error 1.3669	centimeters
Change in Hip Circumference	Betahistine	1.7957	Standard Error 1.3837	centimeters
Change in Hip Circumference	Placebo	1.3668	Standard Error 1.3118	centimeters
Change in Glucose	Betahistine	4.292	Standard Error 2.116	mg/dL
Change in Glucose	Placebo	3.136	Standard Error 2.116	mg/dL

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Betahistine	19
Overall Study	STARTED	Placebo	21
Overall Study	COMPLETED	Betahistine	13
Overall Study	COMPLETED	Placebo	15
Overall Study	NOT COMPLETED	Betahistine	6
Overall Study	NOT COMPLETED	Placebo	6

Source ClinicalTrials.gov

Adverse events12

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	Vomiting	Gastrointestinal disorders	Betahistine	1	19	1
other	Vomiting	Gastrointestinal disorders	Placebo	0	20	0
other	conjunctivitis	Eye disorders	Betahistine	1	19	1
other	conjunctivitis	Eye disorders	Placebo	0	20	0
other	chest pain	Cardiac disorders	Betahistine	0	19	0
other	chest pain	Cardiac disorders	Placebo	1	20	1
other	skin rash	Skin and subcutaneous tissue disorders	Betahistine	0	19	0
other	skin rash	Skin and subcutaneous tissue disorders	Placebo	1	20	1
other	chest pain	Psychiatric disorders	Betahistine	0	19	0
other	chest pain	Psychiatric disorders	Placebo	1	20	1

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Betahistine	0	19
Total, all-cause mortality	Placebo	0	20
Total, other adverse events	Betahistine	2	19
Total, other adverse events	Placebo	4	20
Total, serious adverse events	Betahistine	0	19
Total, serious adverse events	Placebo	0	20

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30542300	DERIVED

Source 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 comparisons2

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

Comparison	Source
Betahistine vs Placebo: deaths from any cause	Trial comparisons
Betahistine vs Placebo: serious adverse events	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.

GET https://conductscience.org/api/trials/v1/NCT00709202

GET https://conductscience.org/api/trials/v1/NCT00709202/results?page=2

API reference For AI assistants