This study evaluates the efficacy and safety of ethosuximide in the treatment of refractory depressive disorder in adults. Half of participants will receive ethosuximide and escitalopram in combination, while the other half will receive a placebo and escitalopram.
Ethosuximide is a inhibitor of low-voltage-sensitive T-type calcium channels(T-VSCCs). It has higher selectivity to T-VSCCs and can enter cerebrospinal fluid through the blood-brain barrier, inhibit T-VSCCs on the lateral habenular nucleus neurons, and then inhibit the cluster discharge of neurons, resulting in a rapid antidepressant effect.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
2 times/day, take it orally after breakfast/dinner; take 500mg in the morning and 500mg in the evening on day1, 500mg in the morning and 750mg in the evening on day2, 750mg in the morning and 750mg in the evening on day3, 750mg in the morning and 1000mg in the evening on day4, 1000mg in the morning and 1000mg in the evening on day5, maintain this dose until the end of treatment for 2 weeks.
2 times/day, take it orally after breakfast/dinner; take 500mg in the morning and 500mg in the evening on day1, 500mg in the morning and 750mg in the evening on day2, 750mg in the morning and 750mg in the evening on day3, 750mg in the morning and 1000mg in the evening on day4, 1000mg in the morning and 1000mg in the evening on day5, maintain this dose until the end of treatment for 2 weeks.
Department of Psychiatry, the First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Montgomery and Asberg Depression Rating Scale(MADRS) score
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Usual cutoff points are: 0 to 6 - normal/symptom absent, 7 to 19 - mild depression, 20 to 34 - moderate depression, \>34 - severe depression. Changes of MADRS score at therapeutic visit point compare with baseline.
Time frame: baseline and 43 days
Quick Inventory of Depressive Symptomatology-Self Report(QIDS-SR) score
The QIDS-SR is a psychological questionnaire used by clinicians to measure 16 factors across 9 different criterion domains for major depression. It is scored by summing the highest response in each of a set of questions relating to sleep, weight and psychomotor symptoms and then adding the remaining items. Scores range from 0 to 27 which may then be categorised as indicating none \[0-5\], mild \[6-10\], moderate \[11-15\], severe \[16-20\] and very severe \[21-27\] depressive symptoms. Changes of QIDS-SR score at therapeutic visit point compare with baseline.
Time frame: baseline and 43 days
Hamilton Anxiety Rating Scale(HAMA) score
The HAMA is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety. Scores range from 0 to 56. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. Lastly, a score of 25 to 30 indicates a moderate to severe anxiety severity. Changes of HAMA score at therapeutic visit point compare with baseline.
Time frame: baseline and 43 days
MADRS score
Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. Changes of individual score of MADRS at therapeutic visit point compare with baseline.
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1 time/day, 20mg/day, take it orally after breakfast, take it for 4 weeks without interruption.
Time frame: baseline and 43 days
Young manic rating scale(YMRS) score
The Young Mania Rating Scale (YMRS) is an eleven-item multiple choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes in children and young adults. The scores from each question are added together to form a total score ranging from 0 to 60, with higher scores indicating a greater severity of symptoms. Extremely high scores increase the risk of the child having bipolar disorder by a factor of 9, while extremely low scores decrease the risk by a factor of 10. A score of 13 or higher indicates a potential case of mania or hypomania, while a score of 21 or above indicates a probable case. The average score for children with mania is 25, while the average score for children with hypomania is 20. Changes of YMRS score at therapeutic visit point compare with baseline.
Time frame: baseline and 43 days
Efficiency after 2 and 4 weeks of treatment.
Efficiency means that the score of MADRS decreases by more than or equal to 50% compared with its baseline score.
Time frame: baseline, week 2 and week 4
Remission rate after 2 and 4 weeks of treatment.
Remission means that the total score of MADRS is less than 10.
Time frame: baseline, week 2 and week 4