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End of Study/Early Withdrawal - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

- 9/20/21 - 1 form, 24 itemgroups, 278 items, 1 language
Itemgroups: Date of visit, ECG, Vital signs, Pharmacokinetics, Blood Sample, Paliperidone, Lab Sample Central Lab, Physical Examination, Abnormal Involuntary Movement Scale, Barnes Akathisia Rating Scale, Simpson Angus Rating Scale, Columbia - Suicide Severity Rating Scale (C-SSRS) Since Last Visit Version, Investigator Evaluation of lnjection site, Positive and Negative Syndrome Scale for Schizophrenia, Clinical Global Impression - Severity, Personal and Social Performance Scale, Medication Preference Questionnaire, Involvement Evaluation Questionnaire (Post-Baseline), Resource Use Questionnaire A Hospitalisation, Resource Use Questionnaire B Emergency room visits without hospitalisation, Resource Use Questionnaire C Day clinic, Resource Use Questionnaire D Night clinic, Resource Use Questionnaire E Outpatient treatment, Resource Use Questionnaire F Daily living, Resource Use Questionnaire G Productivity of subject, Evaluation of relapse
A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01515423 Sponsor: Janssen Research & Development, LLC Other drug name: TREVICTA®

Visit 8 - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

- 9/20/21 - 1 form, 28 itemgroups, 277 items, 1 language
Itemgroups: Date of visit, Randomization, ECG, Vital signs, Pharmacokinetics, Blood Sample, Paliperidone, Lab Sample Central Lab, Urine Dipstick Pregnancy Test, Physical Examination, Abnormal Involuntary Movement Scale, Barnes Akathisia Rating Scale, Simpson Angus Rating Scale, Columbia - Suicide Severity Rating Scale (C-SSRS) Since Last Visit Version, Investigator Evaluation of lnjection site, Subject Evaluation of lnjection site, Positive and Negative Syndrome Scale for Schizophrenia, Clinical Global Impression - Severity, Personal and Social Performance Scale, Administration of trial medication, Medication Preference Questionnaire, Involvement Evaluation Questionnaire (Post-Baseline), Resource Use Questionnaire A Hospitalisation, Resource Use Questionnaire B Emergency room visits without hospitalisation, Resource Use Questionnaire C Day clinic, Resource Use Questionnaire D Night clinic, Resource Use Questionnaire E Outpatient treatment, Resource Use Questionnaire F Daily living, Resource Use Questionnaire G Productivity of subject, Medication Kit Dispensation
A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01515423 Sponsor: Janssen Research & Development, LLC Other drug name: TREVICTA®

Eligibility Treatment-resistant Depression NCT02497287

- 7/27/19 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Criteria, Exclusion Criteria
A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02497287

Eligibility Treatment-resistant Depression NCT02493868

- 7/27/19 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02493868

Eligibility Treatment-resistant Depression NCT02422186

- 7/27/19 - 1 form, 2 itemgroups, 15 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
A Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Participants With Treatment-resistant Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02422186

Eligibility Treatment-resistant Depression NCT02418585

- 7/27/19 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
A Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02418585

Eligibility Treatment Resistant Depression NCT01353092

- 1/23/19 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Pulsating ElectroMagnetive Treatment (PEMF) at Treatment Resistant Depression; ODM derived from: https://clinicaltrials.gov/show/NCT01353092

Eligibility Depressive Disorder, Treatment-Resistant NCT01983904

- 12/17/18 - 1 form, 2 itemgroups, 8 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
DBS for Treatment Resistant Depression; ODM derived from: https://clinicaltrials.gov/show/NCT01983904

Eligibility Treatment Resistant Depression NCT00646087

- 11/8/18 - 1 form, 2 itemgroups, 19 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Ketamine Frequency Treatment for Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00646087

Eligibility Therapy-Resistant Depression DRKS00000021 NCT00273624 - Eligibility Therapy-Resistant Depression NCT00273624

- 6/28/17 - 1 form, 2 itemgroups, 9 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Olanzapine Augmentation Therapy in Treatment-Resistant Depression: a Double-Blind Placebo-Controlled Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00273624

Eligibility Therapy-resistant Depression NCT00276978

- 6/28/17 - 1 form, 2 itemgroups, 9 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Aripiprazole Augmentation Therapy in Treatment-resistant Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00276978

Subject level - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

- 5/28/17 - 1 form, 12 itemgroups, 95 items, 1 language
Itemgroups: DNA Sample, DNA Sample Consent Modification, DNA Sample Replacement, Dermatology Referral, Early withdrawal from Open-Label Phase, End of Double-Blind Phase/Early withdrawal, Adverse Events, Concomitant Therapy, Comments, Relapse, DSM-5 Diagnosis, Subject Identification
A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01515423 Sponsor: Janssen Research & Development, LLC Other drug name: TREVICTA®

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