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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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773 Search results.

WHO-5 - WHO (Five) Well-Being Index

- 4/22/18 - 1 form, 1 itemgroup, 5 items, 30 languages
Itemgroup: Over the last two weeks
WHO (Five) Well-Being Index (1998 version) http://www.who-5.org Also called : WHO Five, WHO 5

Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363 - Psychiatric History

- 11/17/19 - 1 form, 2 itemgroups, 92 items, 1 language
Itemgroups: Psychiatric History, Psychiatric History, Mental disorder, Other
Study ID: 109035 Clinical Study ID: 109035 Study Title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00896363 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK163090 1 mg, GSK163090 Placebo, GSK163090 3 mg Trade Name: Study Indication: Depressive Disorder

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Possible Suicidality-Related Adverse Event

- 11/12/19 - 1 form, 9 itemgroups, 28 items, 1 language
Itemgroups: Administrative Data, General information on possible suicidality-related AE, Suicidality-Related Adverse Event description, Possible suicidality-related adverse event causes, Psychiatric History, Psycho-social stressors, Suicidal ideation, Suicidal behaviour during study, Medical and psychiatric treatment
Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). This form is used to record details about any possible suicidality-related adverse events happening during the study. The event must also be reported on the Adverse Events Form (Non-serious or Serious Adverse Events form as applicable) using the same terminology. Record only 1 event per form.

Eligibility Bipolar Depression NCT01284517

- 8/18/19 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression; ODM derived from: https://clinicaltrials.gov/show/NCT01284517

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Screening - 12-Lead ECG; Subject Identification; Summary Holter; Summary Holter Abnormalities

- 8/14/19 - 1 form, 4 itemgroups, 22 items, 1 language
Itemgroups: 12-Lead ECG, Subject Identification, Summary Holter, Summary Holter Abnormalities
Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT 00814957 - Screen - Inform Screening; Inform Enrolment; Date of visit; Demography; Vitals Signs

- 8/4/19 - 1 form, 10 itemgroups, 40 items, 1 language
Itemgroups: Inform Screening, Inform Enrolment, Date of Visit, Demography, Vital Signs - Measurement 1 Semi-Supine, Vital Signs - Measurement 1 Standing, Vital Signs - Measurement 2 Semi-Supine, Vital Signs - Measurement 2 Standing, Vital Signs - Measurement 3 Semi-Supine , Vital Signs - Measurement 3 Standing
Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Screening - Electronically Transferred Lab Data; Urinalysis

- 8/4/19 - 1 form, 3 itemgroups, 51 items, 1 language
Itemgroups: Electronically Transerred Lab Data, Urinalysis - Dipstick Details, Urinalysis - Microscopy Details
Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Day -1 - 12-Lead ECG; Summary Holter; Summary Holter Abnormalities; Vital Signs; Electronically Transferred Lab Data; Urinalysis; PET; Functional MRI Scan; MRI Scan; Randomisation Number

- 8/4/19 - 1 form, 12 itemgroups, 107 items, 1 language
Itemgroups: Date of Visit, 12-Lead ECG, Summary Holter, Summary Holter Abnormalities, Vital Signs - Pre-Baseline Scan, Electronically Transerred Lab Data , Urinalysis - Dipstick Details , Urinalysis - Microscopy Details , PET - Scan Baseline, Functional MRI Scan, MRI Scan, Randomisation Number
Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Day 1 - Investigational Product; 12-Lead ECG; Vital Signs

- 8/4/19 - 1 form, 31 itemgroups, 176 items, 1 language
Itemgroups: Date of Visit, Investigational Product, 12-Lead ECG Dosing date/time, 12-Lead ECG - Predose, 12-Lead ECG - 1 Hour, 12-Lead ECG - 2 Hour , 12-Lead ECG - 3 Hour, 12-Lead ECG - 5 Hour , 12-Lead ECG - 8 Hour, 12-Lead ECG - 24 Hour , 12-Lead ECG - 36 Hour, 12-Lead ECG - 48 Hour , 12-Lead ECG - Extra Scheduled Assessments Entry, Vital Signs Predose - Semi-Supine, Vital Signs - Dosing Date and Time, Vital Signs Pre-dose - Standing, Vital Signs 1 Hour - Semi-supine, Vital Signs 1 Hour - Standing , Vital Signs 2 Hour - Semi-supine , Vital Signs 2 Hour - Standing , Vital Signs 5 Hour - Semi-supine, Vital Signs 5 Hour - Standing , Vital Signs 8 Hour - Semi-supine, Vital Signs 8 Hour - Standing , Vital Signs 24 Hour - Semi-supine , Vital Signs 24 Hour - Standing, Vital Signs 36 Hour - Semi-supine, Vital Signs 36 Hour - Standing, Vital Signs 48 Hour - Semi-supine, Vital Signs 48 Hour - Standing , Vital Signs - Extra Scheduled Assessments Entry
Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Day 1 - Summary Holter; Summary Holter Abnormalities; Electronically Transferred Lab Data; Pharmacokinetics Blood; Urinalysis

- 8/4/19 - 1 form, 24 itemgroups, 323 items, 1 language
Itemgroups: Date of Visit, Summary Holter, Summary Holter Abnormalities, Electroniclly Transferred Lab Data - Dosing Date and Time, Electronically Transerred Lab Data - Pre-dose, Electronically Transerred Lab Data - 1 Hour, Electronically Transerred Lab Data - 2 Hour , Electronically Transerred Lab Data - 4 Hour, Electronically Transerred Lab Data - 8 Hour , Electronically Transerred Lab Data - 24 Hour, Electronically Transerred Lab Data - 36 Hour , Electronically Transerred Lab Data - 48 Hour, Electronically Transerred Lab Data - 72 Hour , Pharmacokinetics Blood, Pharmacokinetics Blood - Extra Scheduled Samples Entry , Urinalysis - Dosing Date and Time , Urinalysis Dipstick Details - Pre-Dose, Urinalysis Dipstick Details - 2 Hour Post-Dose, Urinalysis Dipstick Details - 4 Hour Post-Dose , Urinalysis Dipstick Details - 8 Hour Post-Dose , Urinalysis Dipstick Details - 24 Hour Post-Dose , Urinalysis Dipstick Details -36 Hour Post-Dose, Urinalysis Dipstick Details -48 Hour Post-Dose , Urinalysis - Local: Microscopy Details
Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Day -1 - PET; Functional MRI Scan

- 8/4/19 - 1 form, 4 itemgroups, 33 items, 1 language
Itemgroups: Date of Visit, PET - Scan 2, Functional MRI Scan, PET - Scan 3
Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Follow-up - Vital Signs; 12-Lead ECG; Electronically Transferred Lab Data; Urinalysis; Study Conclusion; Pregnancy Information

- 8/4/19 - 1 form, 10 itemgroups, 77 items, 1 language
Itemgroups: Date of Visit, Vital Signs - Semi-Supine, Vital Signs - Standing, 12-Lead ECG, Electroniclly Transferred Lab Data - Dosing Date and Time , Electronically Transerred Lab Data, Urinalysis Dipstick Details, Urinalysis - Microscopy Details, Study Conclusion, Pregnancy Information
Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence