donepezil hydrochloride for Anorexia nervosa

Inclusion criteria

• {"criterion_text":"- female"}
• {"criterion_text":"- Presence of 3 DSM V criteria for anorexia nervosa"}
• {"criterion_text":"- Restrictive subtype of anorexia nervosa"}
• {"criterion_text":"- Body Mass Index between 14 and 18.5 kg/m2"}
• {"criterion_text":"- Aged between 18 and 65"}
• {"criterion_text":"- Resting heart rate greater than or equal to 40 bpm"}

Exclusion criteria

• {"criterion_text":"- Past diagnosis of anorexia nervosa in the form of hyperphagia/purgation"}
• {"criterion_text":"- Pregnant or breast-feeding women"}
• {"criterion_text":"- Past diagnosis of bulimia nervosa"}
• {"criterion_text":"- Past diagnosis of binge eating disorder"}
• {"criterion_text":"- Comorbid diagnosis of psychotic disorder and/or bipolar disorder"}
• {"criterion_text":"- Renal impairment (glomerular filtration rate less than 60 mL/min according to the MDRD formula)"}
• {"criterion_text":"- Liver failure or transaminase elevation greater than 5N"}
• {"criterion_text":"- Electrocardiogram of conduction disorder"}
• {"criterion_text":"- Taking a psychotropic drug now or in the three weeks prior to inclusion (including antidepressants, to avoid interaction/potentiation in this population)"}
• {"criterion_text":"- Taking a treatment involving the following cytochromes : P450, P3A4, P2D6"}

Primary endpoints

• {"endpoint_text":"- Absolute intra-individual difference in the total EDE-Q score obtained between inclusion D0 and D90, i.e. (EDE-Qd90 - EDE-Qd0)","definition_or_measurement_approach":"Difference in total EDE-Q score between baseline (D0) and day 90 (D90) measured by the EDE-Q questionnaire (intra-individual change: EDE-Qd90 - EDE-Qd0)."}

Secondary endpoints

• {"endpoint_text":"- Intra-individual difference in body mass index between inclusion D0 and D90, and between D0 and D180","definition_or_measurement_approach":"Change in BMI from baseline (D0) to D90 and from D0 to D180 measured in kg/m2."}
• {"endpoint_text":"- Difference in intra-individual response rates (rate of responses) in the devalued condition of phase 3 \"slip of action\" of the HABITS neurocognitive test between D0 and D90.","definition_or_measurement_approach":"Within-subject change in response rates in the devalued condition of phase 3 of the HABITS test between D0 and D90."}
• {"endpoint_text":"- Intra-individual difference in Self-Report Habit Index (SRHI) scores at D0 and D90 (Davis et al IJED 2020).","definition_or_measurement_approach":"Change in SRHI score from baseline (D0) to D90 using the SRHI instrument."}
• {"endpoint_text":"- Intra-individual difference between scores at D0 and D90 in the Wisconsin Card Sorting Test (WSCT), Trail Making Test B-A and Brixton test.","definition_or_measurement_approach":"Within-subject changes in neuropsychological test scores (WCST, Trail Making Test B-A, Brixton) between D0 and D90."}
• {"endpoint_text":"- Intra-individual difference in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) scores at D0 and D90","definition_or_measurement_approach":"Change in Y-BOCS score from baseline to D90."}
• {"endpoint_text":"- Evolution of EDE-Q and EDI-3 sub-dimensions scores between inclusion D0 and D90","definition_or_measurement_approach":"Change in subscale scores of EDE-Q and EDI-3 between D0 and D90."}
• {"endpoint_text":"- Intra-individual difference in Hospital Anxiety and Depression Scale (HADS) scores between D0 and D90","definition_or_measurement_approach":"Change in HADS score from baseline to D90."}
• {"endpoint_text":"- Evolution of the total EDE-Q score between inclusion D0, D90 and D180.","definition_or_measurement_approach":"Trajectory of total EDE-Q scores measured at D0, D90 and D180."}
• {"endpoint_text":"- Occurrence of adverse events measured according to a standard CTCAE, number of treatment discontinuations due to poor tolerance and changes in biological profile (elevation of transaminases, decrease in PT, prolongation of APTT, increase in CPK, and a disturbance in the blood count formula) performed at D3, D5, D30 and D90","definition_or_measurement_approach":"Safety endpoints: AEs graded by CTCAE, discontinuations due to intolerance, and laboratory parameter changes measured at D3, D5, D30 and D90."}
• {"endpoint_text":"- Collection and storage of plasma and faeces at D1 and D90","definition_or_measurement_approach":"Biospecimen collection (plasma and faeces) at D1 and D90 for storage and future analyses."}

France

Earliest CTIS Part Ii Submission Date

23-05-2024

Latest Decision Or Authorization Date

11-04-2025

Processing Time Days

323

Number Of Sites

3

Number Of Participants

147

Primary sponsor

Full Name

Centre Hospitalier Sainte Anne Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France