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Eligibility Insomnia NCT02290496

- 2016-05-27 - 1 Formulär, 2 Item-grupper, 12 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02290496

Eligibility Insomnia NCT01663844

- 2019-01-16 - 1 Formulär, 2 Item-grupper, 10 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
New Clinical Applications for Internet-based Cognitive Behavior Therapy for Insomnia and Depression; ODM derived from: https://clinicaltrials.gov/show/NCT01663844

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

- 2019-11-15 - 1 Formulär, 2 Item-grupper, 6 Dataelement, 1 Språk
Item-grupper: 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.

Regensburg Insomnia Scale

- 2021-02-11 - 1 Formulär, 1 Item-grupp, 12 Dataelement, 2 Språk
Item-grupp: 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).

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

- 2019-11-12 - 1 Formulär, 9 Item-grupper, 28 Dataelement, 1 Språk
Item-grupper: 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.

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