Treatment – Resistant Depression. Severe depressive episode without psychotic symptoms and Moderate depressive episode
Conditions
Interventions
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 thir
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 we
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.
Sponsors
Vice chancellor for research, Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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 ßHCG 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Effatpanah
Tehran University of Medical Sciences
Outcome results
None listed