The Role of Serotonin 4 Receptor Agonism in Regulating Mood and Cognition in Depression in women (RECAP-D)

Major depressive disorder

Total score on the the 6-item Hamilton Depressive Rating Scale (HRDS-6) after 8 weeks intervention, Total recall score on the Verbal Affective Memory Task 24 (VAMT-24) after 8 weeks of intervention

Time to 50% reduction in HDRS-6 score within the 12-week trial period., Area under the curve (AUC) for RAVLT scores after 2h, and 1, 2 and 4 weeks., AUC for total HDRS-6 scores after 1, 2, 4 and 6 weeks., Total HDRS-6 score at week 12, Total RAVLT score at week 12., Antidepressant treatment intensity rank at week 8 as defined in Table 4 (see protocol). Rankings may be updated according to their degree of treatment escalation in a preregistered statistical analysis plan if additional treatment patterns are identified during the blinded data review., Domain specific endpoint (Brain synaptic density): Latent variable capturing neocortical, hippocampal and neostriatal synaptic vesicle glycoprotein 2A (SV2A) levels from [11C]-UCB-J PET scan at week 4., Domain specific endpoint (Brain synaptic density): Latent variable capturing neocortical, hippocampal and neostriatal [11C]-UCB-J binding / Beck’s Suicide Intention Scale (SSI) at week 4., Domain specific endpoint (Brain synaptic density): Hippocampal [11C]-UCB-J binding / total HDRS-6 score / total RAVLT score at week 4., Domain specific endpoint (Memory encoding): Hippocampal activation during a functional magnetic resonance (fMRI) memory encoding task at week 8., Domain specific endpoint (Working memory function): Prefrontal activation during an fMRI working memory task / total Letter Number Sequence (LNS) score at week 8., Domain specific endpoint (Non-goal-oriented brain network organization): Functional connectivity in DMN and CEN during resting state fMRI (rs-fMRI) brain scan at week 8., Domain specific endpoint (Sleep & activity): Continuous monitoring of vital parameters from the Corsano® CardioWatch system including heart rate, heart rate variability, sleep and steps measured for from baseline until week 2., Domain specific endpoint (Sleep & activity): Total score on the Pittsburgh Sleep Quality Index (PSQI) questionnaire and objective sleep quality measured with the Corsano® CardioWatch system at week 8., Domain specific endpoint (Anhedonia): Ventral striatal activation during an fMRI reward task at week 8., Domain specific endpoint (Anhedonia): Total score of the Changes in Sexual Functioning Questionnaire (CSFQ) at week 8., Domain specific endpoint (Hippocampal neuroplasticity): Hippocampal grey matter volume measured with MRI brain scan at week 8., Domain specific endpoint (Anxiety): General Anxiety Disorder-7 score at week 8, Domain specific endpoint (Metabolic functions): Hypothalamic blood flow response to oral glucose / insulin sensitivity (HOMA-IR) / hba1c (blood sample and MR scan) at week 8., Domain specific endpoint (HPA axis): Cortisol awakening response (CAR) assessed with serial home saliva samples assessed at baseline and week 8., Domain specific endpoint (Gut microbiome): Gut microbiome derived metabolites / gut microbiome from stool samples at week 8, Domain specific endpoint (Gut function): Gastrointestinal rating scale (GSRS) / Bristol stool scale diary at baseline and week 8., Domain specific endpoint (Inflammation): MRI-based extra-neurite mean diffusivity as a proxy for brain inflammation/ hsCRP as a measure of peripheral inflammation / kynurenic acid and kynurenic acid/quinolinic acid ratio (neuroprotective index) at week 8., Domain specific endpoint (Long-term effects): Total score on the Major Depressive Inventory (MDI) 6 months after treatment start., Domain specific endpoint (Long-term effects): Hospitalization, suicide, and treatment switches/add-on based on medical records within 12 months after start of the intervention.

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