Trial Outcomes & Findings for Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain (NCT NCT00709202)

NCT ID: NCT00709202

Last Updated: 2019-01-25

Results Overview

Least Squares estimated change in weight from end of study minus baseline

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 48 participants
• Primary outcome timeframe: Measured at each visit from baseline to end of study over a 12 week period
• Results posted on: 2019-01-25

Participant Flow

48 subjects signed consent for the study. 8 subjects withdrew consent before randomization and another subject withdrew before the first post-baseline measurement. Therefore, only 39 subjects were analyzed.

Participant milestones

Measure	Betahistine Subjects assigned to this arm will receive Betahistine. Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.	Placebo Subjects in this group will received placebo. Placebo: Subjects will be receive placebo tablets matched in number to betahistine tablets
Overall Study STARTED	19	21
Overall Study COMPLETED	13	15
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Measure	Betahistine Subjects assigned to this arm will receive Betahistine. Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.	Placebo Subjects in this group will received placebo. Placebo: Subjects will be receive placebo tablets matched in number to betahistine tablets
Overall Study Withdrawal by Subject	6	6

Baseline Characteristics

Data is presented on 39 subjects who had data sufficient data for analysis of variables of clinical interest-who received at least one post baseline evaluation. One subject discontinued shortly after randomization assignment.

Baseline characteristics by cohort

Measure	Betahistine n=19 Participants Subjects assigned to this arm will receive Betahistine. Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.	Placebo n=20 Participants Subjects in this group will received placebo. Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.	Total n=39 Participants Total of all reporting groups
Age, Continuous	31.1 years STANDARD_DEVIATION 14.9 • n=93 Participants • Data is presented on 39 subjects who had data sufficient data for analysis of variables of clinical interest-who received at least one post baseline evaluation. One subject discontinued shortly after randomization assignment.	31.1 years STANDARD_DEVIATION 14.0 • n=4 Participants • Data is presented on 39 subjects who had data sufficient data for analysis of variables of clinical interest-who received at least one post baseline evaluation. One subject discontinued shortly after randomization assignment.	31.1 years STANDARD_DEVIATION 14.2 • n=27 Participants • Data is presented on 39 subjects who had data sufficient data for analysis of variables of clinical interest-who received at least one post baseline evaluation. One subject discontinued shortly after randomization assignment.
Sex: Female, Male Female	12 Participants n=93 Participants	11 Participants n=4 Participants	23 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	9 Participants n=4 Participants	16 Participants n=27 Participants
Race/Ethnicity, Customized Race-Ethnicity · White-Caucasian	4 Participants n=93 Participants	9 Participants n=4 Participants	13 Participants n=27 Participants
Race/Ethnicity, Customized Race-Ethnicity · Black-African American	7 Participants n=93 Participants	7 Participants n=4 Participants	14 Participants n=27 Participants
Race/Ethnicity, Customized Race-Ethnicity · Hispanic	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Race/Ethnicity, Customized Race-Ethnicity · Other	4 Participants n=93 Participants	0 Participants n=4 Participants	4 Participants n=27 Participants
Region of Enrollment United States	19 participants n=93 Participants	20 participants n=4 Participants	39 participants n=27 Participants

PRIMARY outcome

Timeframe: Measured at each visit from baseline to end of study over a 12 week period

Population: 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.

Least Squares estimated change in weight from end of study minus baseline

Outcome measures

Measure	Betahistine n=19 Participants Subjects assigned to this arm will receive Betahistine. Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.	Placebo n=20 Participants Subjects in this group will received placebo. Placebo Oral Tablet
Change in Weight	-2.0021 kg. (killograms) Standard Error 0.7970	-1.5490 kg. (killograms) Standard Error 0.7650

SECONDARY outcome

Timeframe: Measured at each visit from baseline to end of study over a 12 week period.

Population: 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.

Least Squares estimated change in BMI from end of study minus baseline

Outcome measures

Measure	Betahistine n=19 Participants Subjects assigned to this arm will receive Betahistine. Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.	Placebo n=20 Participants Subjects in this group will received placebo. Placebo Oral Tablet
Change in Body Mass Index (BMI)	-0.5524 kg/m^2 Standard Error 0.2747	-0.5637 kg/m^2 Standard Error 0.2653

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Betahistine n=19 Participants Subjects assigned to this arm will receive Betahistine. Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.	Placebo n=20 Participants Subjects in this group will received placebo. Placebo Oral Tablet
Change in Waist Circumference	4.0928 centimeters Standard Error 1.3884	2.4864 centimeters Standard Error 1.3669

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Betahistine n=19 Participants Subjects assigned to this arm will receive Betahistine. Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.	Placebo n=20 Participants Subjects in this group will received placebo. Placebo Oral Tablet
Change in Hip Circumference	1.7957 centimeters Standard Error 1.3837	1.3668 centimeters Standard Error 1.3118

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Betahistine n=14 Participants Subjects assigned to this arm will receive Betahistine. Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.	Placebo n=14 Participants Subjects in this group will received placebo. Placebo Oral Tablet
Change in Glucose	4.292 mg/dL Standard Error 2.116	3.136 mg/dL Standard Error 2.116

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Betahistine n=14 Participants Subjects assigned to this arm will receive Betahistine. Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.	Placebo n=14 Participants Subjects in this group will received placebo. Placebo Oral Tablet
Change in Cholesterol	1.087 mg/dL Standard Error 0.079	1.010 mg/dL Standard Error 0.079

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Betahistine n=14 Participants Subjects assigned to this arm will receive Betahistine. Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.	Placebo n=14 Participants Subjects in this group will received placebo. Placebo Oral Tablet
Change in LDL	1.799 mg/dL Standard Error 6.633	0.915 mg/dL Standard Error 6.633

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Betahistine n=14 Participants Subjects assigned to this arm will receive Betahistine. Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.	Placebo n=14 Participants Subjects in this group will received placebo. Placebo Oral Tablet
Change in HDL	2.555 mg/dL Standard Error 1.815	-0.840 mg/dL Standard Error 1.815

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Betahistine n=14 Participants Subjects assigned to this arm will receive Betahistine. Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.	Placebo n=14 Participants Subjects in this group will received placebo. Placebo Oral Tablet
Change in Triglycerides	-4.426 mg/dL Standard Error 11.119	-3.360 mg/dL Standard Error 11.119

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Betahistine n=14 Participants Subjects assigned to this arm will receive Betahistine. Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.	Placebo n=17 Participants Subjects in this group will received placebo. Placebo Oral Tablet
Change in Appetite Hunger	-3.605 units on a scale Standard Error .896	-3.684 units on a scale Standard Error .813

SECONDARY outcome

Timeframe: .Measured at baseline and 12 weeks

Least Squares estimated change in appetite fullness 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 full 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 amount of feeling of fullness. The higher the cm number the higher the feeling of fullness. 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.

Outcome measures

Measure	Betahistine n=13 Participants Subjects assigned to this arm will receive Betahistine. Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.	Placebo n=17 Participants Subjects in this group will received placebo. Placebo Oral Tablet
Change in Appetite Fullness	1.800 units on a scale Standard Error 1.058	4.698 units on a scale Standard Error .925

Adverse Events

Betahistine

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Betahistine n=19 participants at risk Subjects assigned to this arm will receive Betahistine. Betahistine: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID.	Placebo n=20 participants at risk Subjects in this group will received placebo. Placebo Oral Tablet
Gastrointestinal disorders Vomiting	5.3% 1/19 • Number of events 1 • 12 weeks during study drug administration We are reporting adverse events reported to IRB (Institutional Review Board) on adverse event forms.	0.00% 0/20 • 12 weeks during study drug administration We are reporting adverse events reported to IRB (Institutional Review Board) on adverse event forms.
Eye disorders conjunctivitis	5.3% 1/19 • Number of events 1 • 12 weeks during study drug administration We are reporting adverse events reported to IRB (Institutional Review Board) on adverse event forms.	0.00% 0/20 • 12 weeks during study drug administration We are reporting adverse events reported to IRB (Institutional Review Board) on adverse event forms.
Cardiac disorders chest pain	0.00% 0/19 • 12 weeks during study drug administration We are reporting adverse events reported to IRB (Institutional Review Board) on adverse event forms.	5.0% 1/20 • Number of events 1 • 12 weeks during study drug administration We are reporting adverse events reported to IRB (Institutional Review Board) on adverse event forms.
Skin and subcutaneous tissue disorders skin rash	0.00% 0/19 • 12 weeks during study drug administration We are reporting adverse events reported to IRB (Institutional Review Board) on adverse event forms.	5.0% 1/20 • Number of events 1 • 12 weeks during study drug administration We are reporting adverse events reported to IRB (Institutional Review Board) on adverse event forms.
Psychiatric disorders chest pain	0.00% 0/19 • 12 weeks during study drug administration We are reporting adverse events reported to IRB (Institutional Review Board) on adverse event forms.	5.0% 1/20 • Number of events 1 • 12 weeks during study drug administration We are reporting adverse events reported to IRB (Institutional Review Board) on adverse event forms.
Psychiatric disorders Increase in level of psychiatric symptoms	0.00% 0/19 • 12 weeks during study drug administration We are reporting adverse events reported to IRB (Institutional Review Board) on adverse event forms.	5.0% 1/20 • Number of events 1 • 12 weeks during study drug administration We are reporting adverse events reported to IRB (Institutional Review Board) on adverse event forms.

Additional Information

Dr. Robert C Principal Investigator. Smith,

Nathan Kline Institute for Psychiatric Research

Phone: 845-398-6531

Email: robert.smith@nki.rfmh.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place