ID

23648

Beschreibung

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

Stichworte

Versionen (1)
  1. 10.07.17 10.07.17 -
Hochgeladen am

10. Juli 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT02307396 DRKS00006878

Englisch

Eligibility Schizophrenia NCT02307396 DRKS00006878

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Diagnosis of schizophrenia or schizoaffective disorder
Beschreibung

Schizophrenia or schizoaffective disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
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)
Beschreibung

Remission

Datentyp

boolean

Alias
UMLS CUI [1]
C0544452
Able to give informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Healthy Volunteers
Beschreibung

Control Group

Datentyp

boolean

Alias
UMLS CUI [1]
C0009932
Actively suicidal
Beschreibung

Suicidal tendency

Datentyp

boolean

Alias
UMLS CUI [1]
C0235196
Serious medical illnesses
Beschreibung

Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
Known non-complience concerning the medication
Beschreibung

Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
Medication with clozapine
Beschreibung

Clozapine

Datentyp

boolean

Alias
UMLS CUI [1]
C0009079
Medication with antidepressants and mood stabilisors that were initiated during the last 6 weeks before study enrollment
Beschreibung

Antidepressants and Mood Stabilizer

Datentyp

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2]
C2917435
Patients with substance dependence other than nicotine or caffeine within 6 months prior to baseline
Beschreibung

Substance Use Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
Unability to give informed consent
Beschreibung

Unability to give informed consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0021430
Pregnancy
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
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Ähnliche Modelle

Eligibility Schizophrenia NCT02307396 DRKS00006878

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
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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