Investigate the Clinical Responses of Ethosuximide in Patients With Treatment-Resistant Depression.
- Conditions
- Depressive Disorder, Treatment-Resistant
- Interventions
- Registration Number
- NCT03887624
- Lead Sponsor
- Zhejiang University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Placebo Placebo(2 weeks)+Escitalopram(4 weeks) Experimental group Escitalopram Ethosuximide(2 weeks) + Escitalopram (4 weeks) Control group Escitalopram Placebo(2 weeks)+Escitalopram(4 weeks) Experimental group Ethosuximide Ethosuximide(2 weeks) + Escitalopram (4 weeks)
- Primary Outcome Measures
Name Time Method Montgomery and Asberg Depression Rating Scale(MADRS） score baseline and 43 days 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.
- Secondary Outcome Measures
Name Time Method MADRS score baseline and 43 days 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.Remission rate after 2 and 4 weeks of treatment. baseline, week 2 and week 4 Remission means that the total score of MADRS is less than 10.
Young manic rating scale(YMRS） score baseline and 43 days 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.Hamilton Anxiety Rating Scale(HAMA） score baseline and 43 days 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.Quick Inventory of Depressive Symptomatology-Self Report(QIDS-SR） score baseline and 43 days 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.Efficiency after 2 and 4 weeks of treatment. baseline, week 2 and week 4 Efficiency means that the score of MADRS decreases by more than or equal to 50% compared with its baseline score.
Trial Locations
- Locations (1)
Department of Psychiatry, the First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China