ID

36342

Beschreibung

Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT02046564

Link

https://clinicaltrials.gov/show/NCT02046564

Stichworte

Versionen (1)
  1. 04.05.19 04.05.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

4. Mai 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT02046564

Englisch

Eligibility Major Depressive Disorder NCT02046564

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who are either inpatients or outpatients.
Beschreibung

Inpatient | Outpatients

Datentyp

boolean

Alias
UMLS CUI [1]
C0021562
UMLS CUI [2]
C0029921
patients who are able to understand necessary information for giving consent to undergo examinations, observations, and evaluations specified in this clinical protocol, and who are able to give written consent based on a full understanding of the trial.
Beschreibung

Protocol Compliance | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
patients who have been given a diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent" according to the dsm-5 and who have a current episode of major depression that has been continuing for at least 8 weeks
Beschreibung

Major depression, single episode | Major Depressive Disorder Recurrent | Major depressive episode Duration

Datentyp

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2,1]
C1269683
UMLS CUI [2,2]
C2945760
UMLS CUI [3,1]
C0024517
UMLS CUI [3,2]
C0449238
patients with a ham-d 17 total score of 18 or more at the screening period evaluation
Beschreibung

Hamilton Depression Rating Scale 17 Item Clinical Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C3639712
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
female patients of childbearing potential who wish to become pregnant during the trial period or within 4 weeks after completion or discontinuation of the trial
Beschreibung

Childbearing Potential Planned Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032992
pregnant or breast-feeding female patients, or female patients who may be pregnant
Beschreibung

Pregnancy | Breast Feeding | Possible pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0425965
patients judged to be intolerant to all antidepressant (including drugs not used for their current episodes of major depression) based on their treatment history
Beschreibung

Intolerance to Antidepressive Agents

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0003289
patients who have had electroconvulsive therapy
Beschreibung

Electroconvulsive Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0013806
patients who have enrolled in a clinical trial of other drugs or medical devices within 1 month before the time of informed consent
Beschreibung

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
patients who have a medical history suggesting a risk of developing serious adverse events or symptoms that may hinder efficacy/safety evaluation (eg, symptoms of fibromyalgia, or premenstrual syndrome etc that overlap with depressive symptoms)
Beschreibung

Adverse event Interferes with Evaluation | Symptoms Interfere with Evaluation | Symptoms Fibromyalgia | Symptoms Premenstrual syndrome | Interference Depressive Symptoms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1261322
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1261322
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0016053
UMLS CUI [4,1]
C1457887
UMLS CUI [4,2]
C0033046
UMLS CUI [5,1]
C0521102
UMLS CUI [5,2]
C0086132
patients with complications or a history of diabetes mellitus, or patients who have been judged to be diabetic
Beschreibung

Complications of Diabetes Mellitus | Diabetes Mellitus | Diabetic

Datentyp

boolean

Alias
UMLS CUI [1]
C0342257
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0241863
fasting blood glucose level ≥ 126 mg/dl
Beschreibung

Fasting blood glucose measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0428568
2-hour glucose level in 75-g oral glucose tolerance test (ogtt) ≥ 200 mg/dl
Beschreibung

Glucose measurement | Oral Glucose Tolerance Test

Datentyp

boolean

Alias
UMLS CUI [1]
C0337438
UMLS CUI [2]
C0029161
non-fasting blood glucose level ≥ 200 mg/dl
Beschreibung

Blood glucose measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0392201
hba1c [ngsp level] ≥ 6.5%
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
patients who are undergoing treatment for thyroid disease (except for patients whose disease has been stabilized with drug therapy for 3 months or longer before the time of informed consent)
Beschreibung

Treatment Thyroid Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0040128
patients who have a history of neuroleptic malignant syndrome or serotonin syndrome
Beschreibung

Neuroleptic Malignant Syndrome | Serotonin Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0027849
UMLS CUI [2]
C0699828
patients who have a history of seizure disorder (eg, epilepsy)
Beschreibung

Epilepsy

Datentyp

boolean

Alias
UMLS CUI [1]
C0014544
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Ähnliche Modelle

Eligibility Major Depressive Disorder NCT02046564

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Inpatient | Outpatients
Item
patients who are either inpatients or outpatients.
boolean
C0021562 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
Protocol Compliance | Informed Consent
Item
patients who are able to understand necessary information for giving consent to undergo examinations, observations, and evaluations specified in this clinical protocol, and who are able to give written consent based on a full understanding of the trial.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Major depression, single episode | Major Depressive Disorder Recurrent | Major depressive episode Duration
Item
patients who have been given a diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent" according to the dsm-5 and who have a current episode of major depression that has been continuing for at least 8 weeks
boolean
C0024517 (UMLS CUI [1])
C1269683 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C0024517 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
Hamilton Depression Rating Scale 17 Item Clinical Classification
Item
patients with a ham-d 17 total score of 18 or more at the screening period evaluation
boolean
C3639712 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Childbearing Potential Planned Pregnancy
Item
female patients of childbearing potential who wish to become pregnant during the trial period or within 4 weeks after completion or discontinuation of the trial
boolean
C3831118 (UMLS CUI [1,1])
C0032992 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Possible pregnancy
Item
pregnant or breast-feeding female patients, or female patients who may be pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0425965 (UMLS CUI [3])
Intolerance to Antidepressive Agents
Item
patients judged to be intolerant to all antidepressant (including drugs not used for their current episodes of major depression) based on their treatment history
boolean
C1744706 (UMLS CUI [1,1])
C0003289 (UMLS CUI [1,2])
Electroconvulsive Therapy
Item
patients who have had electroconvulsive therapy
boolean
C0013806 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
patients who have enrolled in a clinical trial of other drugs or medical devices within 1 month before the time of informed consent
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Adverse event Interferes with Evaluation | Symptoms Interfere with Evaluation | Symptoms Fibromyalgia | Symptoms Premenstrual syndrome | Interference Depressive Symptoms
Item
patients who have a medical history suggesting a risk of developing serious adverse events or symptoms that may hinder efficacy/safety evaluation (eg, symptoms of fibromyalgia, or premenstrual syndrome etc that overlap with depressive symptoms)
boolean
C0877248 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C1457887 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C1457887 (UMLS CUI [3,1])
C0016053 (UMLS CUI [3,2])
C1457887 (UMLS CUI [4,1])
C0033046 (UMLS CUI [4,2])
C0521102 (UMLS CUI [5,1])
C0086132 (UMLS CUI [5,2])
Complications of Diabetes Mellitus | Diabetes Mellitus | Diabetic
Item
patients with complications or a history of diabetes mellitus, or patients who have been judged to be diabetic
boolean
C0342257 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
C0241863 (UMLS CUI [3])
Fasting blood glucose measurement
Item
fasting blood glucose level ≥ 126 mg/dl
boolean
C0428568 (UMLS CUI [1])
Glucose measurement | Oral Glucose Tolerance Test
Item
2-hour glucose level in 75-g oral glucose tolerance test (ogtt) ≥ 200 mg/dl
boolean
C0337438 (UMLS CUI [1])
C0029161 (UMLS CUI [2])
Blood glucose measurement
Item
non-fasting blood glucose level ≥ 200 mg/dl
boolean
C0392201 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c [ngsp level] ≥ 6.5%
boolean
C0474680 (UMLS CUI [1])
Treatment Thyroid Disease
Item
patients who are undergoing treatment for thyroid disease (except for patients whose disease has been stabilized with drug therapy for 3 months or longer before the time of informed consent)
boolean
C0087111 (UMLS CUI [1,1])
C0040128 (UMLS CUI [1,2])
Neuroleptic Malignant Syndrome | Serotonin Syndrome
Item
patients who have a history of neuroleptic malignant syndrome or serotonin syndrome
boolean
C0027849 (UMLS CUI [1])
C0699828 (UMLS CUI [2])
Epilepsy
Item
patients who have a history of seizure disorder (eg, epilepsy)
boolean
C0014544 (UMLS CUI [1])
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