The effect of melatonin on circadian rest-activity rhythms during benzodiazepine tapering in patients with bipolar disorder and comparing it with the control group
The aim of this study was to investigate the effect of melatonin on circadian rest-activity rhythms during benzodiazepine tapering in bipolar patients and comparing it with the control group
Design
Clinical trial with the control group, with parallel groups, single-blind, randomized, phase 3 on 33 participants in each group. block randomized used for randomization.
Settings and conduct
This study conducted at Baharan hospital in Zahedan, patients with bipolar disorder randomized into the intervention and control group. patients blinded to their treatment.
Participants/Inclusion and exclusion criteria
Participants eligible for the trial were 18 years or above; had a
diagnosis of bipolar mood disorder; were treated with at least one antipsychotic drug, and had a daily use of at least one benzodiazepine for a minimum of 3 months.
Participate present with current violent or aggressive behavior; diagnosed with mental retardation, pervasive developmental disorder, dementia, hepatic impairment, terminal illness, severe somatic comorbidity, or epilepsy; had allergic to any compounds in the study medication; breastfeeding women; patients who had a comorbid mental disorder; opioid or any drug use and lack of informed consent excluded from the study.
Intervention groups
Melatonin group: 2 mg once daily for 3 days, and in parallel
they were instructed to gradually reduce their daily benzodiazepine usage. Participants ingested the medication approximately 2 h before bedtime with a small meal.
Placebo group: 2 mg once daily for 3 days, and in parallel
they were instructed to gradually reduce their daily benzodiazepine usage. Participants ingested the study medication approximately 2 h before bedtime with a small meal.
Main outcome variables
Circadian rest-activity rhythms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200913048705N1
Registration date:2022-02-22, 1400/12/03
Registration timing:retrospective
Last update:2022-02-22, 1400/12/03
Update count:0
Registration date
2022-02-22, 1400/12/03
Registrant information
Name
Elham Hajipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3351 3778
Email address
psishahablotfinia@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of melatonin on circadian rest-activity rhythms during benzodiazepine tapering in patients with bipolar disorder and comparing it with the control group
Public title
The effect of melatonin on circadian rest-activity rhythms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 years or above
Had a diagnosis of bipolar mood disorder based on DSM-5
Were treated with at least one antipsychotic drug and had a daily use of at least one benzodiazepine drug for a minimum of 3 months
Exclusion criteria:
Present with current violent or aggressive behavior
Diagnosed with mental retardation, pervasive developmental disorder, dementia,
Physical diseases including hepatic impairment, terminal illness, severe somatic comorbidity, or epilepsy
Allergic to any compounds in the study medication
Fertile women
Breastfeeding women
Lack of informed consent
Comorbid mental disorders
Use of opioids and other drugs
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
The pockets containing medications (melatonin and placebo) were coded, and each code was written on the specific card. Thereafter, eligible patient was assigned to each group, randomly by selecting among shuffling cards. So, allocation sequence was concealed until the moment of assignment, and nobody knows what is the next treatment allocation must be. It should be mentioned that participants, health care providers, assessor and data collector unaware of the assigned intervention (allocated codes).
Blinding (investigator's opinion)
Single blinded
Blinding description
Only participants in this study are blind to whether the drug is melatonin or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Science
Street address
Baharan hospital- Emam Khomeini Ave- Zahedan- Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9819713955
Approval date
2020-12-13, 1399/09/23
Ethics committee reference number
IR.ZAUMS.REC.1399.457
Health conditions studied
1
Description of health condition studied
Bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
Circadian rest-activity rhythms
Timepoint
In days one, two and three
Method of measurement
Actigraph
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with bipolar disorder which take melatonin when their usual benzodiazepine dosage was gradually tapered
Category
Treatment - Drugs
2
Description
Control group: Patients with bipolar disorder which take placebo when their usual benzodiazepine dosage was gradually tapered
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharan hospital
Full name of responsible person
Dr. Elham hajipour
Street address
Baharan hospital- Emam khomeini Ave- Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9819713955
Phone
+98 54 3351 3778
Email
baharanhospital@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Nour-Mohammad Bakhshani
Street address
ZAUMS Main campus, Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
zaums.research@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?