Depression Clinical Trial
— POKAL-PSYOfficial title:
Prediction and Validation of Unipolar Depression With Psychosocial-somatic Markers in a Naturalistic Cohort Recruited in an Outpatient Setting
Verified date | September 2022 |
Source | LMU Klinikum |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The POKAL-PSY project is a study that monitors participants for five years. The goal of the study is to identify distinguishable subtypes of depression on the basis of biomarkers and to gain insight into their prognostic significance.
Status | Not yet recruiting |
Enrollment | 950 |
Est. completion date | October 15, 2032 |
Est. primary completion date | October 15, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - (PHQ>8) if depressed - Subjects of any sex aged between 18-70 - Sufficient ability to speak and understand the german language - Ability to understand and sign the informed consent form Exclusion Criteria: - Cognitive impairment that interferes with reliable completion of questionnaires or answering questions - Presence of manic episode, bipolar disorder, Schizophrenia or schizoaffective disorder (as well as other diseases in the F2 domain in the ICD), active eating disorder, active drug or alcohol dependence syndrome - Presence of uncontrolled systemic disease (e.g. autoimmune disease), uncontrolles somatic (other than metabolic or cardiovascular)/ neurologic diseases, current or recent (last month) physical trauma - Patient with acute suicidal ideation - known deficiency of alpha-1-antitrypsin - pregnant or lactating women |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Psychiatry and Psychotherapy, University Hospital LMU | Munich | Bavaria |
Lead Sponsor | Collaborator |
---|---|
Julia Eder |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in GAF | 4 Weeks | ||
Primary | Changes in MADRS | 4 Weeks | ||
Primary | Alpha-1-Antitrypsin | 1 year | ||
Primary | IGF-1 | 1 year | ||
Primary | weight | 1 year | ||
Secondary | Changes in GAF | 5 years | ||
Secondary | Changes in MADRS | 5 years | ||
Secondary | alpha-1-Antitrypsin | 5 years | ||
Secondary | IGF-1 | 5 years | ||
Secondary | weight | 5 years |
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