Eligibility Schizophrenia NCT02307396 DRKS00006878

ID

23648

Descrição

Responsible Party: Technische Universität München ClinicalTrials.gov Identifier: NCT02307396 History of Changes Other Study ID Numbers: 1723/1-1 2013-000338-37 ( EudraCT Number ) DO 1723/1-1 ( Other Grant/Funding Number: DFG (Deutsche Forschungs Gesellschaft) ) DRKS00006878 ( Other Identifier: Deutsches Register Klinischer Studien ) Study First Received: November 24, 2014 Last Updated: February 29, 2016 Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02307396

Link

https://clinicaltrials.gov/ct2/show/NCT02307396

Palavras-chave

Psychiatry

Eligibility Determination

D012559

10/07/2017 10/07/2017 -

Transferido a

10 de julho de 2017

DOI

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Licença

Creative Commons BY 4.0

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1 Formulários

StudyEvent: ODM
1. Eligibility Schizophrenia NCT02307396 DRKS00006878

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

Inclusion Criteria

Age

Item

Ages Eligible for Study: 18 Years to 65 Years (Adult)

boolean

C0001779 (UMLS CUI [1])

Schizophrenia or schizoaffective disorder

Item

Diagnosis of schizophrenia or schizoaffective disorder

boolean

C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])

Remission

Item

The participants have to be in remission for at least 3 years (i.e. no psychiatric hospitalisation) under a stable antipsychotic medication. Remission will be measured using the remission criteria by Andreasen et al. (2005) Score ≤3 for the items concerning psychosis of the "Positive and Negative Syndrom Scale" (PANSS; Kay et al., 1987): "Delusions" (P1), "Conceptual disorganisation" (P2), "Halluzinations" (P3), "Mannerisms and posturing" (G5) and "Unusual thought content" (G9) and a score ≤3 on the "Clinical Global Impression Severity Scale" (CGI-S; Guy, 1976)

boolean

C0544452 (UMLS CUI [1])

Informed Consent

Item

Able to give informed consent

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

Exclusion Criteria

C0680251 (UMLS CUI-1)

Control Group

Item

Healthy Volunteers

boolean

C0009932 (UMLS CUI [1])

Suicidal tendency

Item

Actively suicidal

boolean

C0235196 (UMLS CUI [1])

Comorbidity

Item

Serious medical illnesses

boolean

C0009488 (UMLS CUI [1])

Compliance

Item

Known non-complience concerning the medication

boolean

C1321605 (UMLS CUI [1])

Clozapine

Item

Medication with clozapine

boolean

C0009079 (UMLS CUI [1])

Antidepressants and Mood Stabilizer

Item

Medication with antidepressants and mood stabilisors that were initiated during the last 6 weeks before study enrollment

boolean

C0003289 (UMLS CUI [1])
C2917435 (UMLS CUI [2])

Substance Use Disorder

Item

Patients with substance dependence other than nicotine or caffeine within 6 months prior to baseline

boolean

C0038586 (UMLS CUI [1])

Unability to give informed consent

Item

Unability to give informed consent

boolean

C1299582 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])

Pregnancy

Item

Pregnancy

boolean

C0032961 (UMLS CUI [1])

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Eligibility Schizophrenia NCT02307396 DRKS00006878