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Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00008176
Date of registration:	29/06/2015
Prospective Registration:	No
Primary sponsor:	Zentralinstitut für seelische Gesundheit
Public title:	Neural and molecular risk mechanisms of autism, affective disorders and psychoses.
Scientific title:	Neural and molecular risk mechanisms of autism, affective disorders and psychoses.
Date of first enrolment:	15/02/2015
Target sample size:	500
Recruitment status:	Recruiting
URL:	http://drks.de/search/en/trial/DRKS00008176
Study type:	observational
Study design:	Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: basic science
Phase:

Countries of recruitment
Germany

Contacts

Name:	Kristina Otto
Address:	J5 68159 Mannheim Germany
Telephone:	+49-621-1703-6522
Email:	kristina.otto@zi-mannheim.de
Affiliation:	Zentralinstitut für seelische Gesundheit

Name:	Carolin Mößnang
Address:	J5 68159 Mannheim Germany
Telephone:	+49-621-1703-6507
Email:	carolin.moessnang@zi-mannheim.de
Affiliation:	Zentralinstitut für seelische Gesundheit

Key inclusion & exclusion criteria

Inclusion criteria: Additional Inclusion Critera:
- all subjects:
o Sufficient german language abilities
o Ability to understand study protocol and give written informed consent
- For healthy controls
o No diagnosis of any psychiatric disorder according to ICD-10 and DSM-IV
o No family history of any psychiatric disorder according to ICD-10 and DSM-IV
- For first grade relatives:
o First grade relative with the diagnosis of ASD, SZ, BP or MD according to ICD-10 or DSM-IV
- For patients:
o Diagnosis of ASD, SZ, BP or MD according to ICD-10 or DSM-IV
Exclusion Criteria:

Exclusion criteria: Exclusion Criteria:
- For women: pregnancy
- MR exclusion criteria (metal implants, brain surgery, permanent makeup)
- Current alcohol or drug abuse
- For healthy controls and first degree relatives: psychiatric disorder according to ICD-10 or DSM-IV

Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pervasive developmental disorders

Recurrent depressive disorder

Schizophrenia

F20
F31
F33
F84

Bipolar affective disorder

Intervention(s)

Group 1: 1. Patients:

• Study content: The study contains standardized and half standardized interviews to confirm the existences and further characterization of the psychiatric disorder. Furthermore a broad battery of questionnaires to access general personality traits and a neuropsychological test battery to characterize the cognitive performance level are assessed. To do genetic analyses a blood sample is taken. The MRI assessment includes a battery of structural and functional sequences.
• Gruppen
- Patienten mit schizophrener Psychose
- Patienten mit bipolarer Störung
- Patienten mit unipolarer Depression
- Patienten mit Autismus

Group 2: 2. Angehörige
• Study content: The study contains a screening interview to access the existence of possible psychiatric disorders. Furthermore a broad battery of questionnaires to access general personality traits and a neuropsychological test battery to characterize the cognitive performance level are assessed. To do genetic analyses a blood sample is taken. The MRI assessment includes a battery of structural and functional sequences.
• Gruppen
- Angehörige mit schizophrener Psychose
- Angehörige mit bipolarer Störung
- Angehörige mit unipolarer Depression
- Angehörige mit Autismus

Group 3: 3. Gesunde Probanden
• Study content: The study contains a screening interview to access the existence of possible psychiatric disorders. Furthermore a broad battery of questionnaires to access general personality traits and a neuropsychological test battery to characterize the cognitive performance level are assessed. To do genetic analyses a blood sample is taken. The MRI assessment includes a battery of structural and functional sequences

Primary Outcome(s)

Identification of multivariate neurocognitive markers, that allow the transdiagnostic classification of patient subgroups according to biological criteria

Secondary Outcome(s)

Find evidence for genetic contributions to disorder-specific and transdiagnostic neurocognitve markers.

Secondary ID(s)

Source(s) of Monetary Support

GABO:milliarium mbH & Co. KG

Projektträger im DLR

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 13/01/2015
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:	http://drks.de/search/en/trial/DRKS00008176#studyResults

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