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Effect of lamotrigine in relapse prevention following intravenous ketamine in depressio

Phase 2
Conditions
Treatment – Resistant Depression.
Severe depressive episode without psychotic symptoms and Moderate depressive episode
F32.1 & F3
Registration Number
IRCT2013110415276N1
Lead Sponsor
Vice chancellor for research, Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
30
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

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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