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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
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dbGaP phs000021 Genome-Wide Association Study of Schizophrenia - Eligibility

- 5/20/22 - 9 forms, 1 itemgroup, 10 items, 1 language
Itemgroup: IG.elig
Principal Investigator: Pablo V. Gejman, MD, NorthShore University HealthSystem (NUH), Evanston, IL, USA MeSH: Schizophrenia https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000021 The goal of the study is to find susceptibility genes for schizophrenia. *Dataset versioning* - Version 1: European-American (EA) ancestry only - Version 2: Version 1 plus African-American (AA) ancestry *Consent groups and participant set* - General research use (GRU): 4591 cases and controls (1217 EA cases, 1442 EA controls, 953 AA cases, 979 AA controls) This consent group includes a subset of schizophrenia cases and all controls (which overlap with Bipolar study controls in Bipolar: GRU dataset). - Schizophrenia and related disorders (SARC): 475 cases (187 EA cases, 288 AA cases) This consent group includes a subset of schizophrenia cases.

pht000067.v2.p2

1 itemgroup 119 items

pht000068.v1.p2

1 itemgroup 38 items

pht000287.v1.p2

1 itemgroup 253 items

Deutsche Version der Northoff Catatonia Rating Scale (NCRS-dv) - Northoff-Katatonie-Screening-Inventar (NCSI-dv)

- 5/17/22 - 2 forms, 4 itemgroups, 12 items, 1 language
Itemgroups: Faktor 1 (affektiv),Faktor 2 (hyperaktiv),Faktor 3 (hypoaktiv),Faktor 4 (verhaltensassoziiert)
Zum klinischen Bild der Katatonie gehören neben eindrucksvollen motorischen Phänomenen wie Rigidität, Dyskinesien, Festination, Gegenhalten, Posieren, Katalepsie, Stereotypien und Manierismen auch affektive Symptome (Aggression, Angst, Affektverflachung, emotionale Labilität etc.) und Störungen des Verhaltens (Mutismus, Autismus, Mitgehen, Echolalie/Eochpraxie etc.). Obwohl im angloamerikanischen Raum insgesamt sieben Skalen zur Erfassung katatoner Symptome für den klinischen und wissenschaftlichen Gebrauch zur Verfügung stehen, existiert im deutschsprachigen Raum lediglich ein validiertes Messinstrument. In dieser Arbeit wird erstmals die deutsche Version der Northoff Catatonia Rating Scale (NCRS-dv) vorgestellt. Die englische Originalversion der Skala (NCRS) erfasst in 40 Items motorische (13 Items), affektive (12 Items) und verhaltensassoziierte (15 Items) katatone Symptome. Die NCRS zeigt sowohl eine hohe interne Konsistenz (Cronbachs α = 0,87) als auch eine hohe Interrater- (r = 0,80–0,96) und Intrarater- (r = 0,80–0,95) Reliabilität. Die Faktorenanalyse der NCRS identifizierte vier Domänen: Affektivität, Hyperaktivität, Hypoaktivität und Verhalten. Die einzelnen Eigenwerte betrugen 8,39, 3,61, 2,98 und 2,82. Diese Werte erklärten 21,5, 9,3, 7,6 und 7,2 % der Varianz. Zusammenfassend stellt die hier vorgelegte NCRS-dv nach Northoff ein zweites Messinstrument im deutschsprachigen Raum zur Erfassung katatoner Symptome dar. Northoff et al. 1999 (Movement Disorders) und Hirjak et al. 2017 (Nervenarzt) Urheber*innen: Georg Northoff Affiliation: Mind, Brain Imaging and Neuroethics Research Unit, The Royal's Institute of Mental Health Research, University of Ottawa, Ottawa, ON, Canada Hirjak, D., Thomann, P. A., Northoff, G., Kubera, K. M., & Wolf, R. C. (2017). Deutsche Version der Northoff Catatonia Rating Scale (NCRS-dv) : Ein validiertes Messinstrument zur Erfassung katatoner Symptome [German version of the Northoff catatonia rating scale (NCRS-dv) : A validated instrument for measuring catatonic symptoms]. Der Nervenarzt, 88(7), 787–796. https://doi.org/10.1007/s00115-016-0136-7

Deutsche Version der Northoff Catatonia Rating Scale (NCRS-dv)

3 itemgroups 40 items

The relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time NCT00945503 - Day 1 - Vital Signs; 12-Lead ECG; Laboratory Results Data (Haematology, Clinical Chemistry) - Pre-Dose and 24h Post-Dose; Urinalysis - Pre-Dose and 24h Post-Dose; Randomisation Number; Investigational Product; Treatment Confirmation; PET Scan (2); fMRI Scan - Post-PET Scan; PET Scan (3); Pharmacokinetics - Blood

- 4/6/22 - 1 form, 16 itemgroups, 158 items, 1 language
Itemgroups: Administrative,Vital Signs,12-Lead ECG,Laboratory Results Data (Haematology) - Pre-Dose,Laboratory Results Data (Clinical Chemistry) - Pre-Dose,Urinalysis - Pre-Dose,Randomisation Number,Investigational Product,Treatment Confirmation,PET Scan (2),fMRI Scan - Post-PET Scan,PET Scan (3),Pharmacokinetics - Blood,Laboratory Results Data (Haematology) - 24hrs Post-Dose,Laboratory Result Data (Clinical Chemistry) - 24hrs Post-Dose,Urinalysis - 24hrs Post-Dose
Study ID: 109731 Clinical Study ID: 109731 Study Title: An adaptive PET study in healthy volunteers using 11C GSK931145 to establish the relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00945503 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1018921 Study Indication: Schizophrenia

PANSS

- 4/6/22 - 1 form, 3 itemgroups, 30 items, 1 language
Itemgroups: Subskala Positivsymptomatik,Subskala Negativsymptomatik,Subskala Globale Symptomatik
Positive and Negative Syndrome Scale (PANSS) + Ergänzung Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261. PMID: 3616518 https://en.wikipedia.org/wiki/Positive_and_Negative_Syndrome_Scale

Eligibility Chronic Schizophrenia NCT00161044

- 11/17/21 - 1 form, 2 itemgroups, 9 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
An Open-Label Investigation of the Adjuvant Therapeutic Effects of Galantamine in Patients With Chronic Schizophrenia and Persistent Deficit Symptoms; ODM derived from: https://clinicaltrials.gov/show/NCT00161044

Eligibility Schizophrenia and Disorders With Psychotic Features NCT00791882

- 9/28/21 - 1 form, 2 itemgroups, 19 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Social Skills Training in Refractory Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00791882

Eligibility Schizophrenia NCT00654706

- 9/20/21 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Efficacy Study Exploring the Effects on Cognition of Sertindole Versus Comparator in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00654706

Eligibility Schizophrenia NCT01165294

- 9/20/21 - 1 form, 2 itemgroups, 16 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
The Effect of Ketamine on Attentiveness; ODM derived from: https://clinicaltrials.gov/show/NCT01165294

Eligibility Schizophrenia NCT00791193

- 9/20/21 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
A Pharmacokinetic Study of the Relative Bioavailability of Paliperidone ER Formulations With Different Release Profiles and a Comparison to Paliperidone IR; ODM derived from: https://clinicaltrials.gov/show/NCT00791193

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

- 9/20/21 - 1 form, 2 itemgroups, 21 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
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 Eligibility Criteria.

Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593 - Week 12 - Visit 11 or Early Withdrawal

- 9/20/21 - 1 form, 8 itemgroups, 58 items, 1 language
Itemgroups: Early Withdrawal,Vital Signs,Physical Examination,Psychiatric Evaluation,Pharmacokinetic Sampling,Atypical Antipsychotic Dosing,Quality of Life Assessment,Investigational Product Dosing
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 Week 12 - Visit 11 or Early Withdrawal.

Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593 - Week 14 - Visit 12: End of Down Titration

- 9/20/21 - 1 form, 2 itemgroups, 34 items, 1 language
Itemgroups: Vital Signs,Physical Examination
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 Week 14 - Visit 12: End of Down Titration.

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