Neural and molecular risk mechanisms of autism, affective disorders and psychoses.
Organizational Data
- DRKS-ID:
- DRKS00008176
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2015-06-29
- Last update in DRKS:
- 2015-06-29
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
The current project aims to 1) enlarge available datasets of healthy controls and first-degree relatives of patients with schizophrenia, bipolar disorder and depression, and 2) collect structural und functional neuroimaging data of patients suffering from these disorders. In addition this established approach will be transferred to autistic spectrum disorder (ASD) and phenotypes concerning social cognition will be collected in addition. Therefore data of patients with ASD and first degree relatives are going to extend current datasets. By applying innovative statistical methods, we aim to identify diagnostic and transdiagnostic neurocognitive markers, as well as their genetic background.
Brief summary in scientific language
The present project will apply an innovative neuroimaging approach, which is based on previous work conducted within the context of the MooDS Consortium. This previous work involved the investigation of psychiatric genetic risk factors in healthy controls and healthy first-degree relatives of patients with psychosis and affective disorders. This project will extend this work to patients with schizophrenia (SCZ), bipolar disorder (BD) and major depression (MD). In addition patients with autism spectrum disorder (ASD) and first degree relatives of patients with ASD will be examined. We will use neuroimaging paradigms established and validated in MooDS and EU-AIMS and apply new and innovative computational methods of analysis in order to discover dimensional neural markers across currently used diagnostic boundaries. We will then correlate these markers with the extended clinical and biological phenotypes of the investigated patients. The goals of this project are therefore to: (1) identify and validate integrative (i.e. imaging, genetics, clinical, environmental) markers for the differential diagnosis of SCZ, BD, MD and ASD; and (2) validate the application of these markers for the prediction of treatment-response, relapse, and side effect development in medicated and un-medicated patients.
Health condition or problem studied
- ICD10:
- F20 - Schizophrenia
- ICD10:
- F31 - Bipolar affective disorder
- ICD10:
- F33 - Recurrent depressive disorder
- ICD10:
- F84 - Pervasive developmental disorders
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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
- Arm 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
- Arm 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
Endpoints
- Primary outcome:
- Identification of multivariate neurocognitive markers, that allow the transdiagnostic classification of patient subgroups according to biological criteria
- Secondary outcome:
- Find evidence for genetic contributions to disorder-specific and transdiagnostic neurocognitve markers.
Study Design
- Purpose:
- Basic research/physiological study
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
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- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center Zentralinstitut für Seelische Gesundheit 68159 Mannheim
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2015-02-15
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 500
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 65 Years
- Additional 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
Addresses
Primary Sponsor
- Address:
- Zentralinstitut für seelische GesundheitProf. Dr. med. Andreas Meyer-LindenbergJ568159 MannheimGermany
- Telephone:
- +49 621 1703-2001
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Zentralinstitut für seelische GesundheitDr. Carolin MößnangJ568159 MannheimGermany
- Telephone:
- +49-621-1703-6507
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Zentralinstitut für seelische GesundheitDipl.psych. Kristina OttoJ568159 MannheimGermany
- Telephone:
- +49-621-1703-6522
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Zentralinstitut für seelische GesundheitDr. Carolin MößnangJ568159 MannheimGermany
- Telephone:
- +49-621-1703-6507
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Projektträger im DLRHeinrich-Konen-Straße 153227 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- GABO:milliarium mbH & Co. KGOskar-von-Miller Ring 2980333 MünchenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2014-11-25
- Ethics committee number:
- 2014-637N-MA
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2015-01-13
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry