Determining the effect of betahistine on olanzapine-induced weight gain in patients with psychosis
Design
Clinical trial with control group, with parallel, randomized, phase 2 and 3 groups on 120 patients. The permutation block method was used for randomization.
Settings and conduct
This double-blind study will be performed to determine the effect of betahistine on olanzapine-induced weight gain in patients with psychosis in Sabzevar Avasei Hospital. Patients will be randomly assigned to the control and intervention groups. For the control group, the usual treatment of olanzapine alone and for the intervention group, in addition to the usual drug olanzapine, he will prescribe betahistine tablets.
Patients in both groups take 5 to 10 mg of olanzapine daily for 73 days, and in these 73 days in the intervention group, betahistine at a dose of 8 mg twice daily (a total of 16 mg daily) with olanzapine will be used.
In this study, the participants in the project and the person implementing the project (researcher) were kept blind.
Participants/Inclusion and exclusion criteria
Not all people with psychosis are treated with olanzapine and do not take effective histamine receptors (antihistamines, etc.).
Intervention groups
We had 60 people in the intervention group (olanzapine + betahistine) and 60 people in the control group (olanzapine alone). Patients in both groups take 5 to 10 mg of olanzapine daily for 73 days, and in these 73 days in the intervention group, betahistine 8 mg twice daily (16 mg daily) was also taken.
Main outcome variables
Weight: the rate of weight gain; Waist circumference: The rate of increase in waist circumference
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210409050910N2
Registration date:2022-04-13, 1401/01/24
Registration timing:retrospective
Last update:2022-04-13, 1401/01/24
Update count:0
Registration date
2022-04-13, 1401/01/24
Registrant information
Name
HOSEIN FAHIMI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4467 2987
Email address
hossein1fahimi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
2021-05-22, 1400/03/01
Actual recruitment end date
2022-02-20, 1400/12/01
Trial completion date
2022-03-01, 1400/12/10
Scientific title
The effect of betahistine on prevention of olanzapine-induced weight gain in patients with psychotic disorder
Public title
The effect of betahistine on prevention of olanzapine-induced weight gain in patients with psychotic disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not all people with psychosis are treated with olanzapine and do not take effective histamine receptors (antihistamines, etc.).
Exclusion criteria:
Patients with concomitant metabolic diseases
Patients who are obese.
Patients taking other weight gain drugs (such as clozapine) at the same time.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
This study is performed as a clinical trial on psychotic patients under standard treatment with olanzapine referred to the medical center of Vasei hospital in Sabzevar after the approval of the ethics committee and obtaining informed written consent of patients referred to the psychiatric clinic of Vasei hospital under the supervision of psychiatric professors. People who have been diagnosed with psychosis according to the DSM5 criteria and are being treated with olanzapine will be selected. After randomization, we will have 60 people in the intervention group (olanzapine + betahistine) and 60 people in the control group (olanzapine alone). Patients in both groups take 5 to 10 mg of olanzapine daily for 73 days, and in these 73 days in the intervention group betahistine at a dose of 8 mg twice a day (16 mg daily) with the start of treatment at the end of treatment in the group. Intervention and in the control group, weight is measured with a specific scale and waist circumference is measured with a meter, and the two groups are compared in terms of weight and waist changes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Road of Tohid shar- Pardis of Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873119
Approval date
2020-02-10, 1398/11/21
Ethics committee reference number
IR.MEDSAB.REC.1398.117
Health conditions studied
1
Description of health condition studied
Psychosis
ICD-10 code
F29
ICD-10 code description
Unspecified psychosis not due to a substance or known physiological condition
Primary outcomes
1
Description
Weight: The rate of weight gain in control and intervention groups
Timepoint
Start treatment, weeks 4 and 8 and end treatment
Method of measurement
Scales
2
Description
Waist circumference: The rate of increase in waist circumference in control and intervention groups
Timepoint
Start treatment, weeks 4 and 8 and end treatment
Method of measurement
Meter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment + betahistine, patients take 5 to 10 mg of olanzapine daily for 73 days and in these 73 days in the intervention group, betahistine 8 mg twice a day (16 mg daily) with olanzapine will be used.
Category
Treatment - Drugs
2
Description
Control group: Routine treatment, Patients take 5 to 10 mg of olanzapine daily for 73 days.