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Eligibility Insomnia NCT02290496

- 27-05-16 - 1 Formulier, 2 Itemgroepen, 12 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02290496

dbGaP phs001253 Pharmacogenetics of Efavirenz Discontinuation for Reported CNS Symptoms - pht006163.v1.p1

- 08-05-23 - 6 Formulieren, 1 Itemgroep, 5 Data-elementen, 1 Taal
Itemgroep: pht006163
Principal Investigator: David W. Haas, MD, Vanderbilt University School of Medicine, Nashville, Tennessee, USA MeSH: Central Nervous System Diseases,Dizziness,Insomnia,Hallucinations,Headache https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001253 This is an evaluation of genetic associations with efavirenz (EFV) discontinuation for central nervous system (CNS) symptoms within 12 months of treatment. Patients were treated at an HIV primary care clinic in Nashville TN from 1998 to 2012. Previously known SNPs in *CYP2B6* and *CYP2A6* were used to define metabolizer genotypes (extensive, intermediate, slow metabolizer). Over 500,000 SNPs from genome-wide genotyping were used to define MDS (Multidimensional Scaling) coordinates to account for population stratification. Patients were defined as *cases* if they discontinued EFV for CNS symptoms within 12 months, otherwise they were defined as *controls* if they did not stop treatment. Among 563 evaluable participants, the hazard ratio for EFV discontinuation for CNS symptoms was 4.9 (95% C.I. 1.9 TO 12.4, p=0.001) in slow metabolizers compared to extensive metabolizers. This association was very significant in Whites 6.5 (95% CI: 2.3 to 18.8; p = 0.001), but not in Blacks 2.6 (95% C.I. 0.5 to 14.1; p = 0.27). The reason for this difference by race is not clear and warrants further investigation.

pht006164.v1.p1

1 Itemgroep 3 Data-elementen

Eligibility

1 Itemgroep 8 Data-elementen

pht006165.v1.p1

1 Itemgroep 12 Data-elementen

pht006166.v1.p1

1 Itemgroep 12 Data-elementen

pht006167.v1.p1

1 Itemgroep 2 Data-elementen

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Logs/Repeats Vital Signs

- 27-09-21 - 1 Formulier, 2 Itemgroepen, 14 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Vital Signs
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). The purpose of this form is to record the results of unscheduled vital sign measurements. There is a seperate form for scheduled measurements. All vital signs should be taken in a sitting position.

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Liver Biopsy

- 20-09-21 - 1 Formulier, 15 Itemgroepen, 161 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Date of liver biopsy, Liver biopsy size, Liver Biopsy Final Diagnosis, Liver Architecture, Description of Hepatocytes, Hepatocyte Inclusions or Vacuoles, Hepatocyte Nuclear Abnormalities, Liver or Lobular Infiltrates, Portal Tract Inflammation, Bile Ducts, Portal Veins, Liver Infections, Parasites or ova in liver biopsy, Histologic Staining of Liver Biopsy or Additional Studies Obtained
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 to be filled in if a liver biopsy is performed because of an Adverse Liver Event. There are seperate forms for general information on the liver event and for liver imaging (if performed).

Regensburg Insomnia Scale

- 11-02-21 - 1 Formulier, 1 Itemgroep, 12 Data-elementen, 2 Talen
Itemgroep: Regensburg Insomnia Scale
Derived from Table 1 from: Crönlein, T., Langguth, B., Popp, R., Lukesch, H., Pieh, C., Hajak, G., Geisler, P. (2013): Regensburg Insomnia Rating Scale (RIS): a new short rating scale for the assessment of psychological symptoms and sleep in insomnia; Study design: development and validation of a new short self-rating scale in a sample of 218 patients suffering from insomnia and 94 healthy controls. Health and Quality of Life Outcomes 2013, 11:65. Published with permission from PD Dr. Tatjana Crönlein. Questionnaire for the assessment of psychological symptoms and sleep parameters of primary insomnia. The questionnaire is particularly suitable for measuring therapeutic changes, for example of cognitive behavioural therapy for insomnia. It asks for cognitive and emotional aspects such as anxiety about sleep and measures the psychophysiological component of insomnia. It is suitable for use in people with insomnia and in people with comorbid or secondary insomnia. Indication: Persons suffering from (primary or secondary) insomnia. May be used for other sleeping disorders as well (see Pieh, C., Bach, M. Popp, R. Jara, C., Crönlein, T., Hajak, G., Geisler, P. (2012): Insomnia symptoms influence CPAP compliance. Sleep and Breathing; 17:99-104.) Purpose: Assessment of the expression of the psychophysiological component of insomnia Implementation and Analysis: Age: Validated on adults Use: The questionnaire contains written instructions. Appropriate answers are to be ticked. Time: 5 minutes The questionnaire contains 10 questions, the patient marks the appropriate numbers on a Likert scale (0 to 4). The Likert scale refers to the frequency of events asked within the previous four weeks. The answers are added up. - inconspicuous: 0 - 12 - conspicuous: 13-24 - marked: 25 – 40 Reliability (Crönlein et al., 2013): high internal consistency (Cronbach alpha 0.890). Validity: Validation of the questionnaire on a sample of 218 patients with a psychophysiological insomnia. Good selectivity to healthy controls. High concurrent validity with the Pittsburgh Sleep Quality Index (PSQI).

Eligibility Insomnia NCT01707706

- 21-04-20 - 1 Formulier, 2 Itemgroepen, 17 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
Acupuncture for Persistent Insomnia Associated With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT01707706

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - BDI

- 15-11-19 - 1 Formulier, 2 Itemgroepen, 6 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Beck Depression Inventory
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 the results of the Beck Depression Index (BDI). To be collected at Visit 1 (Screening) and Visit 4.

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - IVR Pre-Sleep and Post-Sleep Questionnaires

- 15-11-19 - 1 Formulier, 2 Itemgroepen, 6 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Interactive Voice Response Pre- and Post-Sleep Questionnaire
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 the results of the IVR Pre- and Post-Sleep Questionnaires.

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Bedtime Diary - Worksheet for Investigators

- 15-11-19 - 1 Formulier, 4 Itemgroepen, 13 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Bedtime Diary, Bedtimes ordered, Median Habitual Bedtime Calculation
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 calculate the subject's median habitual bedtime from their bedtime diary, to decide when the investigational product is to be taken (60 minutes before habitual bedtime). This form is filled in at least 8 days after the Screening Visit (Visit 1), and before Visit 2.

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Subject Bedtime Diary

- 14-11-19 - 1 Formulier, 2 Itemgroepen, 6 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Bedtime Diary
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). In this form, the subjects record their lights-out time for seven days following the Screening Visit (Visit 1). There is a seperate form for the calculations performed on this data by the investigators.

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Pharmacogenetic Research Consent Withdrawal

- 14-11-19 - 1 Formulier, 2 Itemgroepen, 9 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Withdrawal of consent for Pharmacogenetic Research, DNA sample destruction
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). The purpose of this form is to record whether consent for PGx Pharmacogenetic Research has been withdrawn, and whether the sample was requested to be destroyed.

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Pharmacogenetic Research Consent

- 14-11-19 - 1 Formulier, 2 Itemgroepen, 10 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Pharmacogenetic research consent
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). The purpose of this form is to record whether and when Informed Consent has been obtained for PGx Pharmacogenetic Research.

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