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Fig. 1 | BMC Psychiatry

Fig. 1

From: Neuroimmunological investigations of cerebrospinal fluid in patients with recent onset depression – a study protocol

Fig. 1

Recruitment, inclusion and follow-up. Patients will mainly be recruited from the Referral and Diagnostic Department and healthy volunteers from internet advertisement. Before any examination, the participant will sign the informed consent formula. A variety of potential confounders will be registered by questioning or questionnaires (including body-mass index (BMI), smoking status, current psychotropic and other medication, non-steroid anti-inflammatory drugs (NSAID), alcohol, eating and exercise habits and more). Contraindications to lumbar puncture will be evaluated. Prior to lumbar puncture a neurological examination including neurological evaluation scale to assess neurological soft signs will be performed and blood samples drawn. After the lumbar puncture the WHO Schedules for Clinical Assessment in Neuropsychiatry (SCAN) interview will be conducted (SCAN interview will be conducted prior to lumbar puncture for healthy participants to rule out prior and current psychiatric symptoms). Cognitive testing includes Brief Assessment of Cognition in Schizophrenia (BACS), Montreal Cognitive Assessment (MoCA), Mini-Mental State Examination (MMSE) and Trail Making Test (TMT) A and B. Questionnaires with self-rating of depressive symptoms (Major Depression Inventory (MDI)), quality of life (EQ-5D-5L), diet and exercise will be filled in by the participant. After the visit the following rating scales will be evaluated by the research assistant: Symptom rating (depressive symptoms: Hamilton depression rating scale – 17 items (HAMD-17)/−6 items (HAMD-6) and Montgomery-Asberg Depression Rating Scale - 10 items (MADRS-10)/− 6 items (MADRS-6), manic symptoms: Young Mania Rating Scale (YMRS), anxiety symptoms: Hamilton Anxiety Rating Scale (HAM-A) and psychotic symptoms: Positive and Negative Symptom Scale (PANSS) and Scale for Assessment of Positive/Negative Symptoms (SAPS/SANS)) and functioning by Personal and Social Performance Scale (PSP) and Global Assessment of Functioning. Fecal samples will be collected at home. The participant will be followed up the day after the intervention for the registration of possible side effects. All biological samples will be stored in a biobank for later laboratory analyses. The participant will be followed up after one-two years with repetition of all measurements

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