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IRCT2013110415276N1 IRCT 2014-09-26 Vice chancellor for research, Tehran University of Medical Sciences Effect of lamotrigine in relapse prevention following intravenous ketamine in depression Evaluating Lamotrigine in relapse prevention following intravenous ketamine in 18-65 years old patients with treatment resistant depression in ziaeian hospital in 2013-2014 in a pilot study 2014-09-23 anticipated 30 Complete https://irct.ir/trial/14572 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2 Treatment – Resistant Depression. Intervention 1: Infusion of intravenous Ketamine vials 0/5 mg per Kg of ideal body weight during the 40-minute . oral Lamotrigine tablet 25 mg daily for first and second week,then 50 mg daily for third and fourth week,then 100 mg daily for fifth week and then 200 mg daily for the sixth week for intervention group. Intervention 2: Infusion of intravenous Ketamine vials 0/5 mg per Kg of ideal body weight during the 40-minute . oral placebo tablet daily up to 6 week for control group.
public Mohammad Effatpanah
Ziyaeyan Hospital, Opposite Municipality, Abouzar St.
Tehran Iran (Islamic Republic of) 1366736511 +98 21 5574 5975 m.effatpanah@gmail.com Tehran University of Medical Sciences scientific Mohammad Effatpanah
Ziyaeyan Hospital. Opposite Municipality. Abouzar St.
Tehran Iran (Islamic Republic of) 1366736511 +98 21 5517 6813 m.effatpanah@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 1- patients 18 to 65 years 2- be able to understand the intervention 3- submit their written consent. 4- Being infected with treatment-resistant depression diagnosed by a psychiatrist. 5- current depressive episode lasting 4 to 6 weeks. 6- Be at least at the second stage of TRD (Failure to respond to antidepressant treatment with 2 drug families in the current episode based on Antidepressant Treatment History Form). 7- HDRS score of 21 with Hamilton scoring is higher or equal to 18. 8- Women of reproductive age have negative βHCG and use reliable method of contraception during the study period. Exclusion criteria: 1- patients with depression secondary to medical illness, drug or alcohol abuser (except nicotine and caffeine) according to the criteria of DSMIV. 2- pregnant or lactating women. 3- patients with a history of seizure disorder other than epilepsy and fever. 4- patients with a known history of intolerance or sensitivity to ketamine and lamotrigine. 5- patients with diagnosis of schizophrenia and bipolar disorder, and psychotic signs. 6- patients with Tourette syndrome, autism and mental retardation. 7- patients at serious risk of suicide and homicide. 8- patients with obstructive sleep apnea or a history of difficult airway management in previous anesthesia. 9- patients treated with MAO irreversible inhibitors during the two weeks prior to the intervention. 10- patients with clinical and laboratory evidence of medical disorders, such as impaired hepatic or renal function, coronary disease, cerebrovascular disease, viral hepatitis B and C, acquired immunodeficiency syndrome, diabetes mellitus, uncontrolled hypertension, unmodified hypothyroidism or hyperthyroidism, neurological , immunological or hematologic disorders and in general, patients with clearly abnormal findings in laboratory tests, physical examination, or electrocardiogram. 18 years 65 years Both F32.1 & F3 Severe depressive episode without psychotic symptoms and Moderate depressive episode Treatment - Drugs Treatment - Drugs Infusion of intravenous Ketamine vials 0/5 mg per Kg of ideal body weight during the 40-minute . oral Lamotrigine tablet 25 mg daily for first and second week,then 50 mg daily for third and fourth week,then 100 mg daily for fifth week and then 200 mg daily for the sixth week for intervention group. Infusion of intravenous Ketamine vials 0/5 mg per Kg of ideal body weight during the 40-minute . oral placebo tablet daily up to 6 week for control group. Depression rating scale. Timepoint: 60 minute before the intervention,120 minute,240 minute, 24 and 72 hours after intervention. then once per week up to 6 weeks. Method of measurement: Hamilton Depression Inventory. Vice chancellor for research, Tehran University of Medical Sciences Approved 2014-08-31 Ethics committee of Tehran University of Medical Sciences 6th floor, central building of university, Qods st, Keshavarz blv Tehran Iran (Islamic Republic of)