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Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384 - Investigational Product (Doses AM and PM) and Meal

- 2018-08-21 - 1 Formulär, 5 Item-grupper, 9 Dataelement, 1 Språk

Item-grupper: Experimental drug; Medication dose; a.m., Confirmation; Therapeutic procedure; a.m., Experimental drug; Medication dose; post meridiem, Confirmation; Therapeutic procedure; post meridiem, Meal (occasion for eating)

Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram Study Indication: Depressive Disorder and Anxiety Disorders

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Pharmacogenetic Research, Prior And Concomitant Medication, Baseline Signs And Symptoms

- 2021-09-20 - 1 Formulär, 3 Item-grupper, 28 Dataelement, 1 Språk

Item-grupper: Pharmacogenetic Research, prior medication, baseline signs and symptoms

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Pharmacogenetic Research, Prior And Concomitant Medication, Baseline Signs and Symptoms

Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593 - Investigational Product

- 2018-04-19 - 1 Formulär, 1 Item-grupp, 6 Dataelement, 1 Språk

Item-grupp: Investigational Product

Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains Investigational Product.

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Serious Adverse Event, Form D, Investigator Comment Log, Investigator's Statement

- 2017-08-06 - 1 Formulär, 5 Item-grupper, 38 Dataelement, 1 Språk

Item-grupper: serious adverse event, laboratory data, death form, investigator comment log, investigator checklist

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Follow-Up Serious Adverse Event, Form D, Investigator Comment Log, Investigator's Statement

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Concomitant Medication, Adverse Event

- 2017-08-06 - 1 Formulär, 2 Item-grupper, 20 Dataelement, 1 Språk

Item-grupper: concomitant medication, adverse event

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Follow-Up Concomitant Medication, Adverse Event

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Laboratory Collections, Pregnancy Information, Study Conclusion

- 2017-08-05 - 1 Formulär, 3 Item-grupper, 13 Dataelement, 1 Språk

Item-grupper: clinical chemistry and hematology, pregnancy information, study conlcusion

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Follow-Up Laboratory Collections, Pregnancy Information, Study Conclusion

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dextrometorphan Urine Collection, Vital Signs 4, 12-Lead ECG Monitoring 4, Laboratory Collections 6

- 2017-08-03 - 1 Formulär, 5 Item-grupper, 26 Dataelement, 1 Språk

Item-grupper: dextrometorphan urine collection, vital signs, 12-lead ecg, clinical chemistry and hematology, urinanalysis

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Treatment Period 2 Dextrometorphan Urine Collection, Vital Signs 4, 12-Lead ECG Monitoring 4, Laboratory Collections 6

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dosing Details 13-17, PK Sampling 3-5

- 2017-07-30 - 1 Formulär, 8 Item-grupper, 30 Dataelement, 1 Språk

Item-grupper: dosing details, pk sampling, dosing details, dosing details, dosing details, dosing details, pk sampling, pk sampling

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Treatment Period 2 Dosing Details 13-17, PK Sampling 3-5

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Laboratory Collections 5, Dosing Details 11-12, PK Sampling 1-2

- 2017-07-30 - 1 Formulär, 4 Item-grupper, 14 Dataelement, 1 Språk

Item-grupper: clinical chemistry and hematology, urinanalysis, dosing details, pk sampling

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Treatment Period 2 Laboratory Collections 5, Dosing Details 11-12, PK Sampling 1-2

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dosing Details 7-10, Vital Signs 3, 12-Lead ECG Monitoring 3

- 2017-07-30 - 1 Formulär, 3 Item-grupper, 19 Dataelement, 1 Språk

Item-grupper: dosing details, vital signs, 12-lead ecg

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Treatment Period 2 Dosing Details 7-10, Vital Signs 3, 12-Lead ECG Monitoring 3

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Vital Signs 2, 12-Lead ECG Monitoring 2, Laboratory Collections 4 - GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Vital Signs, 12-Lead ECG Monitoring, Laboratory Collections 4

- 2017-07-30 - 1 Formulär, 4 Item-grupper, 22 Dataelement, 1 Språk

Item-grupper: vital signs, 12-lead ecg, clinical chemistry and hematology, urinanalysis

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Treatment Period 2 Vital Signs 2, 12-Lead ECG Monitoring 2, Laboratory Collections 4

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Laboratory Collections 3, Dosing Details 4-6 - GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Laboratory Collections 3, Dosing Details

- 2017-07-29 - 1 Formulär, 3 Item-grupper, 9 Dataelement, 1 Språk

Item-grupper: clinical chemistry and hematology, urinanalysis, dosing details

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Treatment Period 2 Laboratory Collections 3, Dosing Details 4-6

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