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Evaluation the Effect of Agomelatine on Sleep, Anxiety, Depression, Appetite and Fatigue in Hematopoietic Stem Cells Transplant Recipients

Protocol summary

Study aim
Comparison of Agomelatine with Placebo in order to obtain a suitable Drug for Sleep Disorders, Anxiety, Depression, Fatigue and Anorexia in Recipients of Hematopoietic Stem Cell Transplants.
Design
A Placebo-Controlled, Triple-Blind, Randomized, Phase 3 Clinical Trial on 80 Patients.
Settings and conduct
This study will be conducted in the Bone Marrow Transplant Department of Taleqani General Hospital in Tehran. The intervention group will receive 25 mg of agomelatine and the control group will receive placebo every night during hospitalization. Patients, principal investigator and data analyst will be blinded
Participants/Inclusion and exclusion criteria
All candidate Patients for Hematopoietic Stem Cell Transplantation will be admitted to the Hospital where the Study is conducted. Inclusion criteria: Consent to enter the study; Age group 18 to 75 years; No history of liver and kidney diseases; Normal liver enzymes. Exclusion criteria: Lack of Consent to enter the Study; History of Sensitivity to Agomelatine; Taking Drugs affecting Appetite; Simultaneous use of Drugs with significant Interaction with Agomelatine.
Intervention groups
The use of agomelatine drug at a dose of 25 mg every night in the patients of the intervention group during the hospitalization of the patients. Evaluation of Pittsburgh Sleep Quality Index, Hospital Anxiety and Depression Scale, Council on Nutrition Appetite Questionnaire and Brief Fatigue Inventory in the three stages at the beginning of hospitalization, during the neutropenia period and at the end of hospitalization. The Use of Placebo in the Control Group during the Hospitalization of the Patients and the Completion of the above questionnaires in the three time periods mentioned.
Main outcome variables
PSQI score؛ CNAQ score؛ HADS score؛ BFI score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100127003210N28
Registration date: 2024-06-26, 1403/04/06
Registration timing: prospective

Last update: 2024-06-26, 1403/04/06
Update count: 0
Registration date
2024-06-26, 1403/04/06
Registrant information
Name
Maria Tavakoli Ardakani
Name of organization / entity
Faculty of pharmacy, Shaid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
mariatavakoli@sbmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-07-11, 1403/04/21
Expected recruitment end date
2025-07-12, 1404/04/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the Effect of Agomelatine on Sleep, Anxiety, Depression, Appetite and Fatigue in Hematopoietic Stem Cells Transplant Recipients
Public title
Evaluation the Effect of Agomelatine on Sleep, Anxiety, Depression, Appetite and Fatigue in Hematopoietic Stem Cells Transplant Recipients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients' satisfaction to enter the study Patients aged more than 18 years and less than 75 years old who are candidates for bone marrow stem cell transplantation. Weight of at least 40 kg Creatinine clearance ≥ 30 mL/min due to renal elimination of drug metabolites Liver enzymes (ALT, AST) less than three times the upper limit of normal If the patients suffer from anxiety or depression, they are equally divided into two groups, case and control.
Exclusion criteria:
Patients' lack of consent to enter the study Pregnancy and breastfeeding History of allergy to agomelatine or any of the components of the drug formulation History of underlying liver, kidney, thyroid disorders and untreated anemia in patients History of bipolar disorder, mania and hypomania Taking drugs that affect appetite, such as vitamins of group B and zinc Consumption of stimulants such as amphetamine derivatives, or consumption of narcotic drugs Simultaneous use of drugs with significant interactions with agomelatine, such as rifampin, ciprofloxacin, and fluvoxamine.
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization. Patients are divided into 20 blocks of 4 individuals, and different interventions are performed for patients based on the type of group (placebo or intervention). Each category will be assigned a code, and based on that code, the medicine or placebo code will be presented to the participants, and the performer is unaware of the code assigned to the medicine or placebo. In this method, Sealed Envelope software with the following internet address is used. This site is a free site for randomization in clinical trials. https://www.sealedenvelope.com/ The Randomization Unit is clustered.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this Study, the Participants, Principal Investigator, Data and Safety Monitoring Committee, Outcome Assessor and Data Analyst will not know the Type of Intervention. The Research Project Associate divides the Drug and Placebo into the Patient's Drug Collection.
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Faculty of Pharmacy, Shahid Beheshti University of Medical Science, Valiasr St., Hashemi Rafsanjani Highway intersection., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1996835113
Approval date
2024-05-27, 1403/03/07
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1403.044

Health conditions studied

1

Description of health condition studied
Patients with various Blood Malignancies who are candidates for Hematopoietic Stem Cell Transplantation.
ICD-10 code
C81
ICD-10 code description
Hodgkin lymphoma

Primary outcomes

1

Description
Sleep Quality
Timepoint
At the Beginning of the Patient's Hospitalization and before the Intervention, At the Time of Neutropenia and At the End of the Hospitalization and before Discharge.
Method of measurement
Pittsburgh Sleep Quality Index

2

Description
Hospital Anxiety and Depression Score
Timepoint
At the Beginning of the Patient's Hospitalization and before the Intervention, At the Time of Neutropenia and at the End of the Hospitalization and before Discharge.
Method of measurement
Hospital Anxiety and Depression Scale Questionnaire

3

Description
Anorexia
Timepoint
At the Beginning of the Patient's Hospitalization and before the Intervention, At the Time of Neutropenia and at the End of the Hospitalization and before Discharge.
Method of measurement
Council on Nutrition Appetite Questionnaire

4

Description
Fatigue level
Timepoint
At the Beginning of the Patient's Hospitalization and before the Intervention, At the Time of Neutropenia and at the End of the Hospitalization and before Discharge.
Method of measurement
Brief Fatigue Inventory Questionnaire

Secondary outcomes

1

Description
Length of hospitalization
Timepoint
At the End of the Study
Method of measurement
Counting days of hospitalization

2

Description
The need to take sleep aids
Timepoint
During the entire hospital stay
Method of measurement
Registering and reporting the number of patients who need to be prescribed hypnotic drugs in each study group

Intervention groups

1

Description
Intervention group: 25 mg of Agomelatine drug from Agulip brand manufactured by Tadbir Kalaye Jam (tekaje) company will be taken orally by the patient every night during hospitalization.
Category
Treatment - Drugs

2

Description
Control group: The placebo prepared by the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences will be used orally by the patient every night during the hospitalization period.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleqani General Hospital
Full name of responsible person
Dr. Maria Tavakoli Ardakani
Street address
Taleghani General Hospital, Next to Shahid Beheshti University of Medical Sciences, Shahid Arabi St, Yemen St, Shahid Chamran highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۷۴۱۳
Phone
+98 21 2243 2565
Email
info@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Hamed Barabadi
Street address
Shahid Beheshti Faculty of Pharmacy, No. 2660, Valiasr Street, Tehran
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 0118
Email
pharmacy@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maria Tavakoli Ardakani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Niayesh Educational Complex, Intersection of Niayesh and Valiasr St
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
mariatavakoli@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maria Tavakoli Ardakani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Niayesh Educational Complex, Intersection of Niayesh and Valiasr St
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
mariatavakoli@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maria Tavakoli Ardakani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Niayesh Educational Complex, Intersection of Niayesh and Valiasr St
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8887 3704
Email
mariatavakoli@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Therapeutic findings of the intervention can be shared by statistical analysis without providing patient names.
When the data will become available and for how long
6 month after publishing the results, primary outcome data will be released.
To whom data/document is available
Doctors and other researchers
Under which criteria data/document could be used
People such as hospital staff or other medical staff such as nurses and clinical pharmacists can use this information.
From where data/document is obtainable
Researchers can contact the following email to receive information: mariatavakoli@yahoo.com
What processes are involved for a request to access data/document
People who intend to use the information must be affiliated with reliable organizations and their requests should be submitted through these organizations. In this context, there is a need for an introduction letter from the desired center.
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