The purpose of this study is to investigate the effectiveness of adding one injection and two intravenous injections of ketamine to mood stabilizing treatments in the treatment of bipolar depression with a control group.
Design
A clinical trial with control and intervention groups, with parallel groups, blinded, randomized, phase 4 on 60 patients. The rand function of Excel software was used for randomization
Settings and conduct
Ibn Sina Hospital, Mashhad, diagnosed with bipolar depression
Participants/Inclusion and exclusion criteria
Inclusion criteria include: age 18 to 65 years; Patients who have been treated with full-dose anti-depressants for at least 8 weeks; Completing the written informed consent form.
Inclusion criteria: substance abuse
Intervention groups
One group is injected with 0.5 mg/kg body weight of ketamine (within 40 minutes) and the control group is injected with normal saline. Patients' symptoms are evaluated using criteria at the beginning of the study, 90 minutes and days 1, 7, 30 and 60 after injection. Also, Hamilton's depression and Beck's anxiety criteria will be used to evaluate patients at the same time.
Main outcome variables
Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101130005280N58
Registration date:2022-10-06, 1401/07/14
Registration timing:prospective
Last update:2022-10-06, 1401/07/14
Update count:0
Registration date
2022-10-06, 1401/07/14
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2022-10-25, 1401/08/03
Expected recruitment end date
2023-10-25, 1402/08/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of add on trial of single or double dose of intravenousKetamine to usual treatment with mood stabilizers in treating bipolardepression
Public title
Efficacy of ketamine in the treatment of depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have received a depressive episode by a doctor diagnosing bipolar disorder (one and two)
In the last two weeks (since the start of sampling) there has been no significant change in their medication regimen
Exclusion criteria:
Patients with severe physical illness (especially hypertension)
History of substance use and dependence in the past month
Age
From 18 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
This is how random numbers are prepared with the help of Randomaize.com. According to the number of research samples, a number of envelopes with wrappers
Alumni (in order to avoid the clarity of the contents of the envelopes), are prepared and each of the random sequences created on a card is recorded and the cards inside the envelopes are better named. In order to maintain a random sequence, also on the outer surface of the envelopes.
The issuance number is done in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively.
At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the envelopes have the odd number of the control group and the envelopes have an even number.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Random numbers table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical sciences
Street address
Qoreishi Building, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
123456
Approval date
2014-07-23, 1393/05/01
Ethics committee reference number
922343
Health conditions studied
1
Description of health condition studied
Bipolar depression
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
depression
Timepoint
base line and 90 minutes, 1 day, 7 days, 30 days and 60 days after infusion
Method of measurement
Hamilton depression questionnaire
2
Description
anxiety
Timepoint
base line and 90 minutes, 1 day, 7 days, 30 days and 60 days after infusion
Method of measurement
Beck anxiety scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group will receive normal saline.
Category
Placebo
2
Description
Intervention group: Ketamine in dose of 0.5 milligram/kilogram will be infused over 40 minutes in case group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn e Sina Hospital
Full name of responsible person
Dr Mahnaz Abedian.
Street address
Ibn e Sina Hospital, Bu-Ali Sq, Amel Blvd, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
123456
Phone
+98 51 3764 7197
Email
fahimeh.afzaljavan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour
Street address
Qoreishi Building, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
123456
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Ali Talaei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ibn e Sina Hospital, Bu-Ali Sq, Amel Blvd, Mashhad, Iran.