Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Maastricht University
With
P1vital Products LTD.
Biotrial
University Hospital Frankfurt, Department of Psychiatry, Psychosomatic Medicine and Psychotherapy
The Institute of Neuropsychiatry and Addictions (INAD), Parc de Salut Mar, Barcelona
Aristotle University Of Thessaloniki
Maastricht University, School for Mental Health and Neuroscience
Age
20–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
General:
1. Be able to provide signed and dated informed consent for study participation.
2. Be male or female, aged between 20 and 55 years, inclusive.
3. Be able to read, write, and speak the language in which psychometric tests are provided, with acceptable visual and auditory acuity (corrected if necessary).
4. Unless otherwise stated, CNS medications to treat symptoms of MDD or SZ and other stable CNS conditions requiring medication is permitted in the MDD and SZ groups, provided the daily dose of medication has not been changed by more than +/- 30% in the last 4 weeks before the start of the study, and is not expected to change by a larger fraction while participating in the study.
MDD
Participants must:
1. Have a primary Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnosis of MDD, confirmed by the result of the MINI interview conducted by the site at screening. Subjects with a diagnosis of comorbid Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Panic Disorder or specific phobia may be included.
2. Meet the DSM-5 criteria for a current Major Depressive Episode, with the current depressive episode not having lasted longer than 6 months.
3. If undergoing treatment, be currently treated with an antidepressant approved in this protocol for at least 4 continuous weeks. Psychological treatments (e.g., Cognitive Behaviour Therapy, Interpersonal Psychotherapy, Psychodynamic Psychotherapy etc.) are all permitted in this study regardless of frequency and duration.
SZ
Subjects must:
1. Have a primary diagnosis of schizophrenia according to the Statistical Manual of Mental Disorders 5th edition (DSM-5), confirmed by the result of the MINI interview conducted by the site at screening. Subjects with a diagnosis of comorbid Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Panic Disorder or specific phobia may be included.
2. Dose of antipsychotics not exceeding the equivalent of 6 mg risperidone.
Clareo Health | Validating Reward-related Biomarkers (RTOC)
