ID

23648

Description

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

Keywords

Versions (1)
  1. 7/10/17 7/10/17 -
Uploaded on

July 10, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Schizophrenia NCT02307396 DRKS00006878

English

Eligibility Schizophrenia NCT02307396 DRKS00006878

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

boolean

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

Schizophrenia or schizoaffective disorder

Data type

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)
Description

Remission

Data type

boolean

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

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Healthy Volunteers
Description

Control Group

Data type

boolean

Alias
UMLS CUI [1]
C0009932
Actively suicidal
Description

Suicidal tendency

Data type

boolean

Alias
UMLS CUI [1]
C0235196
Serious medical illnesses
Description

Comorbidity

Data type

boolean

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

Compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Medication with clozapine
Description

Clozapine

Data type

boolean

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

Antidepressants and Mood Stabilizer

Data type

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
Description

Substance Use Disorder

Data type

boolean

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

Unability to give informed consent

Data type

boolean

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

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
Back to the top of the page

Similar models

Eligibility Schizophrenia NCT02307396 DRKS00006878

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial