1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
05 Nov 2022
The effect of prazosin on improving sleep quality in patients with depressive disorder
Protocol summary
Study aim
Inclusion of prazosin in the treatment protocol of patients with depressive disorders with nightmares
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3, on 60 patients, a table of numbers was used for randomization.
Settings and conduct
Patients with depression referred to the clinic of Sabzevar Vasei Hospital and Dr. Hossein Fahimi's office, which were confirmed by the Beck questionnaire, are divided into two groups of intervention and control and are studied for at least eight weeks. The dose of prazosin for the intervention group is 1 mg daily. The control group received placebo. Patients' sleep quality is then evaluated by the Petersburg questionnaire at weeks zero, four and eight.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with depressive disorder and complaints of sleep quality disorders who have not responded to routine treatments to improve sleep quality. Non-entry conditions: Patients with depression with psychotic feature Patients with mixed phase diagnosis Patients with concomitant physical illness Substance use
Intervention groups
Patients with depression confirmed by the Beck questionnaire are divided into intervention and control groups and are studied for at least eight weeks. The dose of prazosin for the intervention group is 1 mg daily, which is prescribed in addition to routine
antidepressants. The control group received placebo in addition to routine antidepressants. Patients' sleep quality is then evaluated by the Petersburg questionnaire at weeks zero, four and eight.
Main outcome variables
Frequent difficulty falling asleep midnight or early morning waking snoring and bloating during sleep feeling of extreme cold or heat during sleep or during sleep
nightmares complaints of pain during sleep complaints of drowsiness during daily activities Use medication to fall asleep
General information
Reason for update Acronym
IRCT registration information
IRCT registration number: IRCT20210409050910N1 Registration date: 2021-05-24, 1400/03/03
Registration timing: registered_while_recruiting
Last update: 2021-05-24, 1400/03/03 Update count: 0
Registration date 2021-05-24, 1400/03/03 Registrant information
Name
HOSEIN FAHIMI
Name of organization / entity Country
Iran (Islamic Republic of) Phone
+98 51 4467 2987 Email address
[email protected] Recruitment status
Recruitment complete Funding source
Expected recruitment start date 2021-04-29, 1400/02/09
Expected recruitment end date 2022-09-21, 1401/06/30 Actual recruitment start date
empty
Actual recruitment end date
2 empty
Trial completion date empty
Scientific title
The effect of prazosin on improving sleep quality in patients with depressive disorder
Public title
Evaluation of prazosin effects on depression Purpose
Treatment
Inclusion/Exclusion criteria Inclusion criteria:
Confirmation of depression disorder by Beck inventory Confirmation of sleep disorders by Pittsburg sleep quality index. Failed to respond to other ordinary medication of sleep disorders
Exclusion criteria:
Age
No age limit Gender
Both Phase
3
Groups that have been masked Participant
Investigator Sample size
Target sample size: 54
Randomization (investigator's opinion) Randomized
Randomization description
Randomization using Shuffle block Randomization unit:
individual In this method, we have two treatment groups, T is considered as a group of 27 receiving prazosin and C is considered as a group of 27 placebo, we will have different states including six blocks, which include these cases. TTCCTT. TCTCTC.CTCTCT.CCTTCC. CCTTCC.
CTCTCC. …. We use these modes in the form of cards with alternate random allocation. For a sample size of 54 people, we use the above cards with replacement 9 times.
Blinding (investigator's opinion) Double blinded
Blinding description
Using a placebo with the same shape and specifications as the drug used in the study, which is used for the control group, and also placing patients randomly in the intervention and control groups, of which neither the patient nor the researcher is aware.
Placebo 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
Tohid Shahr Road - Sabzevar University of Medical Sciences Campus - Block B - Research Management of the School of Medicine
City Sabzevar Province
Razavi Khorasan Postal code
9613873119 Approval date
2021-03-09, 1399/12/19
Ethics committee reference number IR.MEDSAB.REC.1399.191
Health conditions studied
1
Description of health condition studied
Sleep problems in patients with depressive disorder ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Sleep quality of patients with depressive disorder Timepoint
Weeks 0, 4 and 8 after starting prazosin Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes empty
Intervention groups
1
Description
Control group: Patients admitted to this group receive a placebo with exactly the same characteristics as the drug used in the study (prazosin). Placebo, like the drug under study, is given once a day for eight weeks.
Patients' sleep quality is measured using the Pittsburgh Questionnaire at weeks 0, 4 and 8.
Category Placebo
3
2
Description
Intervention group: Patients in this group take prazosin at a dose of 1 mg daily once a day. The drug is
prescribed for eight weeks. Patients' sleep quality is measured using the Pittsburgh Questionnaire at weeks 0, 4 and 8.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center Vasei Hospital
Full name of responsible person Hossein Fahimi
Street address
Tohid Shahr Boulevard - Vasei Hospital City
Sabzevar Province
Razavi Khorasan Postal code
9617747431 Phone
+98 51 4465 1300 Email
[email protected] Web page address
https://www.medsab.ac.ir/index.aspx?siteid=1&fkeyid
=&siteid=1&pageid=9388
Sponsors / Funding sources
1 Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences Full name of responsible person
Mohhamadhossein Saghi Street address
Nuclear Martyrs Boulevard, above the Memorial of the Unknown Martyrs, Campus of the University of Medical Sciences, Vice Chancellor for Research and Technology
City Sabzevar Province
Razavi Khorasan Postal code
9617913114 Phone
+98 51 4401 8101 Email
[email protected] Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences Full name of responsible person
Hossein Fahimi Position
Assistant Professor Latest degree
Specialist
Other areas of specialty/work Psychiatrics
Street address
Sabzevar, Nuclear Martyrs Boulevard, Extensive Educational Hospital
City Sabzevar Province
Razavi Khorasan Postal code
9617747431 Phone
+98 51 4465 1300 Email
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences Full name of responsible person
Hossein Fahimi Position
Assistant Professor Latest degree
Specialist
Other areas of specialty/work Psychiatrics
Street address
Sabzevar, Nuclear Martyrs Boulevard, Extensive Educational Hospital
City
4 Sabzevar
Province
Razavi Khorasan Postal code
9617747431 Phone
+98 51 4465 1300 Email
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences Full name of responsible person
Hossein Fahimi Position
Assistant Professor Latest degree
Specialist
Other areas of specialty/work Psychiatrics
Street address
Sabzevar, Nuclear Martyrs Boulevard, Extensive Educational Hospital
City sabzevar Province
Razavi Khorasan Postal code
9617747431 Phone
+98 51 4465 1300 Email
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
Not applicable Data Dictionary Not applicable
Title and more details about the data/document All data can potentially be shared after unidentified individuals. The study protocol, statistical analysis map, informed consent form and clinical study report can be fully shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific or industrial institutions
Under which criteria data/document could be used Researchers working in academic and scientific or industrial institutions
From where data/document is obtainable Hossein Fahimi Email: [email protected] What processes are involved for a request to access data/document
Send email to the person in charge Comments
