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IRCT20101130005280N58 IRCT 2022-10-06 Mashhad University of Medical Sciences Efficacy of ketamine in the treatment of depressive disorder Efficacy of add on trial of single or double dose of intravenousKetamine to usual treatment with mood stabilizers in treating bipolardepression 2022-10-25 anticipated 60 Complete https://irct.ir/trial/5649 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Random numbers table, 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. 4 Bipolar depression. Intervention 1: Control group will receive normal saline. Intervention 2: Intervention group: Ketamine in dose of 0.5 milligram/kilogram will be infused over 40 minutes in case group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is En After finishing work, consult with colleagues and it will be published if all members
public Ali Talaei
Ibn e Sina Hospital, Bu-Ali Sq, Amel Blvd, Mashhad, Iran.
Mashhad Iran (Islamic Republic of) 1234654 +98 51 3711 2701 pbsrc@mums.ac.ir Mashhad University of Medical Sciences scientific Ali Talaei
Ibn-e-Sina Hospital, Bu-Ali Sq., Amel Blvd., Mashhad,Iran.
Mashhad Iran (Islamic Republic of) 123456 +98 51 3711 2701 mantegia@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 18 years 65 years Both Patients with severe physical illness (especially hypertension) History of substance use and dependence in the past month F31 Bipolar disorder Placebo Treatment - Drugs Control group will receive normal saline. Intervention group: Ketamine in dose of 0.5 milligram/kilogram will be infused over 40 minutes in case group. Depression. Timepoint: base line and 90 minutes, 1 day, 7 days, 30 days and 60 days after infusion. Method of measurement: Hamilton depression questionnaire. Anxiety. Timepoint: base line and 90 minutes, 1 day, 7 days, 30 days and 60 days after infusion. Method of measurement: Beck anxiety scale. Mashhad University of Medical Sciences Approved 2014-07-23 Ethics Committee of Mashhad University of Medical sciences Qoreishi Building, Daneshgah St. Mashhad Razavi Khorasan Iran (Islamic Republic of)