The aims of this study are to evaluate the effect of intravenous infusion of ketamine in response to treatment of treatment-resistant depression and the effect of oral Lamotrigine maintenance therapy after intravenous infusion of ketamine.
The study was designed as a randomized, double blind, placebo-controlled, single-center, and phase II clinical trial.
30 patients will choose from 18 to 65 years old patients, who admitted to the Psychiatric Clinic of Ziaeian hospital based on inclusion criteria.
Inclusion criteria are: 18 to 65 years old patients with treatment resistant depression, the current episode of depression lasting at least 4 to 6 weeks, be at least at the second stage of TRD. And also HDRS score of 21 with Hamilton scoring is higher or equal to 18.
Exclusion criteria are: Patients with depression secondary to medical illness, drug or alcohol abuse, pregnant or lactating women, patients with medical or psychiatric comorbidities, patients with a known history of intolerance or sensitivity to ketamine, patients at serious risk of suicide and homicide, patients with obstructive sleep apnea or a history of difficult airway management in previous anesthesia, patients treated with MAO irreversible inhibitors during the two weeks prior to the intervention, and in general, patients with clearly abnormal findings in laboratory tests, physical examination, or electrocardiogram.
The diagnosis is based on interviews by two psychiatrists on DSMIV criteria. The depression levels will determine based on Hamilton Depression Inventory. Consent from clients who have volunteered to participate in the research will done, the patient will continue their previous medications. After arriving at the operating room, patients will receive standard monitoring include pulse oxymetry, ECG, NIBP. An IV line number 20 will be placed. For patients, 0 / 5mg / kg ketamine based on ideal body weight (IBW) will infuse over 40 minutes. Patients will be monitored for 24 hours in the ward. Patients will complete the Hamilton questionnaire 60 minutes before the intervention, and also, 120 min, 240 min and 24 and 72 hours after intervention. Patients who responding in this stage while continue previous medications will randomly divide into two groups (Intervention/Control). The intervention group will be treated with oral Lamotrigine (25 mg daily for first and second week, 50 mg daily for third and fourth week, 100 mg daily for fifth week and 200 mg daily for the sixth week). Control group will receive placebo for 6 weeks. Both groups will complete Hamilton questionnaire every week up to 6 weeks. Then two intervention and control groups will be compared in terms of scoring.