ID

36362

Description

A Safety, Efficacy and Biomarker Study of JNJ-42847922 in Participants With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT02476058

Lien

https://clinicaltrials.gov/show/NCT02476058

Mots-clés

Versions (1)
  1. 07/05/2019 07/05/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

7 mai 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT02476058

Anglais

Eligibility Major Depressive Disorder NCT02476058

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
before randomization, a woman must be either: 1) not of childbearing potential: postmenopausal; permanently sterilized; or otherwise be incapable of pregnancy. 2) of childbearing potential and practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for participants participating in clinical studies: example, established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (iud) or intrauterine system (ius) in combination with barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap with spermicidal foam/gel/film/cream/suppository; male partner sterilization; true abstinence. women must agree to continue using these methods of contraception throughout the study and for at least 3 months after receiving the last dose of study medication
Description

Childbearing Potential Absent | Postmenopausal state | Female Sterilization Permanent | Female infertility | Childbearing Potential Contraceptive methods | Contraceptives, Oral, Hormonal | Contraceptive injection | Contraceptive implant | Intrauterine Devices | Uses intrauterine system contraception | Contraception, Barrier | Female Condoms | Spermicidal foam/jelly/cream/film/suppository | CERVICAL CAP FOR CONTRACEPTIVE USE | Partner Male sterilization | Sexual Abstinence

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0232970
UMLS CUI [3,1]
C0015787
UMLS CUI [3,2]
C0205355
UMLS CUI [4]
C0021361
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0700589
UMLS CUI [6]
C0009907
UMLS CUI [7]
C1656586
UMLS CUI [8]
C1657106
UMLS CUI [9]
C0021900
UMLS CUI [10]
C3164761
UMLS CUI [11]
C0004764
UMLS CUI [12]
C0221829
UMLS CUI [13]
C3843415
UMLS CUI [14]
C0493327
UMLS CUI [15,1]
C0682323
UMLS CUI [15,2]
C0024559
UMLS CUI [16]
C0036899
participant body mass index (bmi) must be between 18 and 30 kilogram per square meter (kg/m2) inclusive
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
participant must meet the diagnostic and statistical manual of mental disorders-iv (dsm-iv) or 5 diagnostic criteria for major depressive disorder (mdd) without psychotic features, and confirmed by the mini international neuropsychiatric interview (mini) 6.0; participant must have an inventory of depressive symptomatology- clinician rated-30 (ids-c30) total score greater than or equal to (>=) 30; participant is either currently antidepressant naive or currently being treated with a maximum of two concurrent antidepressants. if the subject is currently treated with antidepressants, they have to be given at an optimal dose and for at least 4 weeks, but not longer than 24 weeks with a suboptimal response
Description

DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE | Inventory of Depressive Symptomatology Clinical Classification | Antidepressive Agents Absent | Antidepressive Agents Quantity Dose Optimal

Type de données

boolean

Alias
UMLS CUI [1]
C0743081
UMLS CUI [2]
C4330496
UMLS CUI [3,1]
C0003289
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0003289
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0178602
UMLS CUI [4,4]
C2698651
a man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug
Description

Gender Sexually active Barrier Contraception | Partner Childbearing Potential | Gender Vasectomy Absent | Condoms, Male | Spermicidal foam/jelly/cream/film/suppository | Partner Vaginal contraceptive diaphragm | Partner CERVICAL CAP FOR CONTRACEPTIVE USE | Gender Sperm donation Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0004764
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C3831118
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0042387
UMLS CUI [3,3]
C0332197
UMLS CUI [4]
C0009653
UMLS CUI [5]
C3843415
UMLS CUI [6,1]
C0682323
UMLS CUI [6,2]
C0042241
UMLS CUI [7,1]
C0682323
UMLS CUI [7,2]
C0493327
UMLS CUI [8,1]
C0079399
UMLS CUI [8,2]
C0871414
UMLS CUI [8,3]
C0332197
participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
Description

Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who is pregnant or breast feeding
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's study responsible physician, is considered cured with minimal risk of recurrence)
Description

Malignant Neoplasms | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Malignant Neoplasm Cured

Type de données

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0553723
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0006826
UMLS CUI [5,3]
C1880198
participant has a primary dsm diagnosis of general anxiety disorder (gad), panic disorder, obsessive compulsive disorder (ocd), posttraumatic stress disorder (ptsd), anorexia nervosa, or bulimia nervosa. subjects with comorbid gad, social anxiety disorder (sad), or panic disorder for whom mdd is considered the primary diagnosis are not excluded
Description

Generalized Anxiety Disorder | Panic Disorder | Obsessive-Compulsive Disorder | Post-Traumatic Stress Disorder | Anorexia Nervosa | Bulimia Nervosa

Type de données

boolean

Alias
UMLS CUI [1]
C0270549
UMLS CUI [2]
C0030319
UMLS CUI [3]
C0028768
UMLS CUI [4]
C0038436
UMLS CUI [5]
C0003125
UMLS CUI [6]
C2267227
participant has a length of current major depressive episode (mde) >24 months despite adequate treatment
Description

Major depressive episode Duration | Therapy Adequate failed

Type de données

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205411
UMLS CUI [2,3]
C0231175
participant has failed more than 2 treatments with a different pharmacological mode of action despite an adequate dose and duration during a previous, or the current depressive episode
Description

Pharmacotherapy Quantity Dose Adequate | Pharmacotherapy failed Depressive episode

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205411
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0231175
UMLS CUI [2,3]
C0349217
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Similar models

Eligibility Major Depressive Disorder NCT02476058

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Childbearing Potential Absent | Postmenopausal state | Female Sterilization Permanent | Female infertility | Childbearing Potential Contraceptive methods | Contraceptives, Oral, Hormonal | Contraceptive injection | Contraceptive implant | Intrauterine Devices | Uses intrauterine system contraception | Contraception, Barrier | Female Condoms | Spermicidal foam/jelly/cream/film/suppository | CERVICAL CAP FOR CONTRACEPTIVE USE | Partner Male sterilization | Sexual Abstinence
Item
before randomization, a woman must be either: 1) not of childbearing potential: postmenopausal; permanently sterilized; or otherwise be incapable of pregnancy. 2) of childbearing potential and practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for participants participating in clinical studies: example, established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (iud) or intrauterine system (ius) in combination with barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap with spermicidal foam/gel/film/cream/suppository; male partner sterilization; true abstinence. women must agree to continue using these methods of contraception throughout the study and for at least 3 months after receiving the last dose of study medication
boolean
C3831118 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3,1])
C0205355 (UMLS CUI [3,2])
C0021361 (UMLS CUI [4])
C3831118 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C0009907 (UMLS CUI [6])
C1656586 (UMLS CUI [7])
C1657106 (UMLS CUI [8])
C0021900 (UMLS CUI [9])
C3164761 (UMLS CUI [10])
C0004764 (UMLS CUI [11])
C0221829 (UMLS CUI [12])
C3843415 (UMLS CUI [13])
C0493327 (UMLS CUI [14])
C0682323 (UMLS CUI [15,1])
C0024559 (UMLS CUI [15,2])
C0036899 (UMLS CUI [16])
Body mass index
Item
participant body mass index (bmi) must be between 18 and 30 kilogram per square meter (kg/m2) inclusive
boolean
C1305855 (UMLS CUI [1])
DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE | Inventory of Depressive Symptomatology Clinical Classification | Antidepressive Agents Absent | Antidepressive Agents Quantity Dose Optimal
Item
participant must meet the diagnostic and statistical manual of mental disorders-iv (dsm-iv) or 5 diagnostic criteria for major depressive disorder (mdd) without psychotic features, and confirmed by the mini international neuropsychiatric interview (mini) 6.0; participant must have an inventory of depressive symptomatology- clinician rated-30 (ids-c30) total score greater than or equal to (>=) 30; participant is either currently antidepressant naive or currently being treated with a maximum of two concurrent antidepressants. if the subject is currently treated with antidepressants, they have to be given at an optimal dose and for at least 4 weeks, but not longer than 24 weeks with a suboptimal response
boolean
C0743081 (UMLS CUI [1])
C4330496 (UMLS CUI [2])
C0003289 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0003289 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C2698651 (UMLS CUI [4,4])
Gender Sexually active Barrier Contraception | Partner Childbearing Potential | Gender Vasectomy Absent | Condoms, Male | Spermicidal foam/jelly/cream/film/suppository | Partner Vaginal contraceptive diaphragm | Partner CERVICAL CAP FOR CONTRACEPTIVE USE | Gender Sperm donation Absent
Item
a man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0004764 (UMLS CUI [1,3])
C0682323 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3,1])
C0042387 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0009653 (UMLS CUI [4])
C3843415 (UMLS CUI [5])
C0682323 (UMLS CUI [6,1])
C0042241 (UMLS CUI [6,2])
C0682323 (UMLS CUI [7,1])
C0493327 (UMLS CUI [7,2])
C0079399 (UMLS CUI [8,1])
C0871414 (UMLS CUI [8,2])
C0332197 (UMLS CUI [8,3])
Protocol Compliance
Item
participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
women who is pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant Neoplasms | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Malignant Neoplasm Cured
Item
participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's study responsible physician, is considered cured with minimal risk of recurrence)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0553723 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C1880198 (UMLS CUI [5,3])
Generalized Anxiety Disorder | Panic Disorder | Obsessive-Compulsive Disorder | Post-Traumatic Stress Disorder | Anorexia Nervosa | Bulimia Nervosa
Item
participant has a primary dsm diagnosis of general anxiety disorder (gad), panic disorder, obsessive compulsive disorder (ocd), posttraumatic stress disorder (ptsd), anorexia nervosa, or bulimia nervosa. subjects with comorbid gad, social anxiety disorder (sad), or panic disorder for whom mdd is considered the primary diagnosis are not excluded
boolean
C0270549 (UMLS CUI [1])
C0030319 (UMLS CUI [2])
C0028768 (UMLS CUI [3])
C0038436 (UMLS CUI [4])
C0003125 (UMLS CUI [5])
C2267227 (UMLS CUI [6])
Major depressive episode Duration | Therapy Adequate failed
Item
participant has a length of current major depressive episode (mde) >24 months despite adequate treatment
boolean
C0024517 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0205411 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
Pharmacotherapy Quantity Dose Adequate | Pharmacotherapy failed Depressive episode
Item
participant has failed more than 2 treatments with a different pharmacological mode of action despite an adequate dose and duration during a previous, or the current depressive episode
boolean
C0013216 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205411 (UMLS CUI [1,4])
C0013216 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0349217 (UMLS CUI [2,3])
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