The augmentation effect of injectable scopolamine in the improvement of clinical symptoms of patients with major depressive disorder
Design
The current clinical trial study has a control group, with parallel groups, without blinding, randomized (using block randomization), phase 3 on 46 patients.
Settings and conduct
In this randomization clinical trial, patients with major depressive disorder with minimum severity of Hamilton depression scale 20 referred to Amirkabir Arak hospital were divided into two equal groups of standard treatment and scopolamine treatment by means of block randomization. In the standard treatment group, patients will receive standard treatment and in the scopolamine group, patients will receive 0.5 mg of scopolamine intramuscularly daily for three days. Finally, two groups will be evaluated in terms of the desired outcome.
Participants/Inclusion and exclusion criteria
Eligibility conditions: patients with major depressive disorder; age 55-18 years; Minimum severity of depression based on Hamilton Depression Scale should be higher or equal to 20. Conditions for not entering the study: presence of psychotic disorder; delirium and bipolar, pregnancy or breastfeeding; taking psychedelic drugs, antidepressants in the last month; ECT in the last two months; history of cardiovascular disease; Hypothyroidism
Intervention groups
In the standard treatment group, patients will receive the standard treatment of major depressive disorder. In the scopolamine treatment group, in addition to the standard treatment of major depressive disorder, patients will receive 0.5 mg of scopolamine intramuscularly daily for three days.
Main outcome variables
Hamilton depression scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231017059749N1
Registration date:2023-10-21, 1402/07/29
Registration timing:prospective
Last update:2023-10-21, 1402/07/29
Update count:0
Registration date
2023-10-21, 1402/07/29
Registrant information
Name
Amin Hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3369 1709
Email address
drhoseini.amin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-22, 1402/07/30
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The augmentation effect of injectable scopolamine in the improvement of clinical symptoms of patients with major depressive disorder
Public title
The effect of injectable scopolamine in patients with major depressive disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with major depressive disorder
Age 18-55 years
Minimum severity of depression based on Hamilton Depression Scale should be higher or equal to 20.
Exclusion criteria:
The existence of psychotic disorder, delirium and bipolar disorderPregnancy or breastfeeding
Taking psychedelic drugs, antidepressants in the last month
ECT in the last two months
History of cardiovascular disease
Hypothyroidism
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomized block method will be used for randomization into two groups of scopolamine (group A) and treatment with standard treatment (group B). For this purpose, a block of 4 will be used. Four cards are selected, the letter A is written on two cards, and the letter B is written on the other two cards. In order to hide the cards, they are placed inside the envelope and turned over several times so that the order is not clear. When each participant enters, a card is selected for him and the selected card is discarded; This work is also done for the next patient to determine 4 people. Then, in the same way, randomization will be done for other groups of 4 people to reach the desired sample size.
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 Arak University of Medical Sciences
Street address
Vice chancellor for research, Arak University of Medical Sciences, Basij Square, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2022-08-28, 1401/06/06
Ethics committee reference number
IR.ARAKMU.REC.1401.168
Health conditions studied
1
Description of health condition studied
Major depressive disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Hamilton depression scale
Timepoint
The beginning of the study, the fourth day, the seventh day, the fourteenth day, the twenty-eighth day
Method of measurement
Hamilton questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to standard treatment (SSRI), patients will receive 0.5 mg scopolamine intramuscularly daily for three days.
Category
Treatment - Drugs
2
Description
Intervention group: Patients will receive standard treatment (SSRI).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak Amir Kabir Hospital
Full name of responsible person
Dr. Anita Alaghmand
Street address
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819691187
Phone
+98 918 393 3024
Fax
+98 86 3222 2003
Email
daalaghmand@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Mehdi Salehi
Street address
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3532
Fax
+98 86 3417 3532
Email
salehi58@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kmali
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mehran Shayeganfard
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
mshayganfard@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Ali Sabouri
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819691187
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
ali.sabouri1987@gmail.com
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study.
When the data will become available and for how long
Access will be from 2024/01/20 to 2027/01/20 for 3 years.
To whom data/document is available
University researchers
Under which criteria data/document could be used
Academic researchers or university professors or students who intend to use the data of this study, after obtaining permission from the relevant people mentioned, can use the information of this study in the field of metallurgical studies or other relevant review studies. In addition, if requested, they can use the information of this study for the prerequisites of their future studies and the existence of questions and ambiguities. Using the information of this study is subject to mentioning the names and logos of the responsible persons in this study.
From where data/document is obtainable
Academic researchers and university professors can request the use of data from Dr. Ali Sabouri after contacting the relevant official via message or email. Dr. Ali Sabouri: Phone: 09126031453 Email: ali.sabouri1987@gmail.com Address: Arak, Amirkabir Hospital, Hospital Education Vice-Chancellor
What processes are involved for a request to access data/document
Letter writing should be done with professors and universities.