ESCITALOPRAM for Major depressive disorder | Bipolar disorder (current depressive episode) | Anxiety disorder | Schizophrenia | Schizoaffective disorder

Stratification factors

• diagnosis

Inclusion criteria

• {"criterion_text":"- Suffer from a depressive episode (major depressive disorder and bipolar disorder (currently depressive episode)) (as assessed by the MINI in agreement with DSM-5 criteria) of at least moderate severity (assessed using the Structured Interview Guide for the Hamilton Depression Scale (SIGH-D) with a score of 14 or higher) and/or suffer from an anxiety disorder (for example panic disorder, social phobia, specific phobia, agoraphobia, generalised anxiety disorder) (as assessed by the MINI in agreement with DSM-5 criteria) of at least moderate severity (assessed using the Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) with a score of 18 or higher) and/or suffer from a psychotic disorder (schizophrenia and schizoaffective disorder) (as assessed by the MINI in agreement with DSM-5 criteria) of at least moderate severity (assessed using the Positive and Negative Symptom Scale (PANSS) with a score of 75 or higher)"}
• {"criterion_text":"- Have had an inadequate response to at least 1 psychotropic treatment during their life-time. Inadequate response is defined as insufficient efficacy of a psychotropic treatment when dosed high enough and maintained long enough, or discontinuation of a psychotropic treatment due to AEs or intolerability"}
• {"criterion_text":"- Are about to switch (or have switched within the last 2 weeks prior to first contact with an investigator) to sertraline or escitalopram (for patients with mood or anxiety disorders), or to aripiprazole or risperidone (for patients with psychotic disorders) due to an inadequate response to or intolerance of the current/ previous medication."}
• {"criterion_text":"- Currently receiving inpatient or outpatient psychiatric treatment"}
• {"criterion_text":"- Be able to understand the requirements of the study and provide written informed consent to participate in this study; a signed and dated informed consent form (ICF) will be obtained from each patient before any procedure of the study."}
• {"criterion_text":"- To give written consent to the use and disclosure of clinical data from their medical records for the purpose of this study"}
• {"criterion_text":"- Age between ≥18and <65 years"}
• {"criterion_text":"- Women of child-bearing potential must have a negative pregnancy test in serum/urine before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion,vasectomized partner and sexual abstinence. Hormonal contraceptive methods is accepted because there are no additional risk for this trial."}

Exclusion criteria

• {"criterion_text":"- Patients with a history of prior pharmacogenomic testing"}
• {"criterion_text":"- Patients with no prior use of psychotropic medication (medication-naïve patients)"}
• {"criterion_text":"- Severe somatic comorbidities as reported in the subject’s medical history or based on clinical chemistry/electrocardiography (ECG) results up to six months ago. If any of these comorbidities is detected on the basis of physical examination and/or clinical chemistry and/or ECG at the screening visit, participation is not possible: Liver disease defined as follows: Alanine-Aminotransferase (ALAT) >70u/L; Renal disease defined as: Estimated glomerular filtratrion rate (eGFR) < 60mL/min/1.73m2; Uncontrolled diabetes considering screening blood tests (Blood glucose > 11.1 mmol/L or two timestwice fasting glucose > 7.0 mmol/L); Cardiac disease defined as: prolonged QT-interval"}
• {"criterion_text":"- Alcohol and/or substance abuse and/or dependence (except nicotine) , allowing mild substance/ alcohol use disorder (as assessed by the MINI in agreement with DSM-5 criteria)."}
• {"criterion_text":"- Polypharmacy defined as the routine use of five or more medications including over-the-counter, prescription and/or traditional and complementary medicines used by a patient (WHO 2019) , excluding the study medication."}
• {"criterion_text":"- Pregnant or breastfeeding women"}

Primary endpoints

• {"endpoint_text":"- Patient recovery at 24 weeks, as assessed using the patient recovery assessment scale (RAS, RAS-DS))","definition_or_measurement_approach":"Assessed at 24 weeks using the Patient Recovery Assessment Scale (RAS, RAS-DS)."}

Secondary endpoints

• {"endpoint_text":"- Well-being and quality of life (EuroQol 5 Dimensions-5 levels questionnaire; EQ-5D-5L). Psychosocial functioning (Functioning Assessment Short Test (FAST)). Clinical symptomatology (SIGH-D; for patients with mood disorders), (SIGH-A; anxiety disorders), and the PANSS (for psychotic patients). Side effects (Frequency, Intensity and Burden of side effects ratings (FIBSER) and the Udvalg for Kliniske Undersogelse – Side Effects Rating Scale (UKU-SERS)). Obtained over a 24-week period","definition_or_measurement_approach":"Measured over 24 weeks using EQ-5D-5L for quality of life, FAST for psychosocial functioning, SIGH-D (mood disorders), SIGH-A (anxiety disorders), PANSS (psychotic patients), and FIBSER and UKU-SERS for side effects."}

Methods

• Site-based recruitment at participating psychiatric hospitals/clinics (Spain: Hospital Clinic De Barcelona; Germany: Universitaetsklinikum Bonn AöR; Ludwig Maximilian University Of Munich; Netherlands: Parassia Groep B.V.).
• Use of recruitment materials and public-facing documents: factsheets, flyers and posters (country-specific recruitment material files present for Spain, Germany and Netherlands).
• Study information and ICF distribution at participating sites (subject information sheets and ICF documents available in multiple languages).

Spain

Earliest CTIS Part Ii Submission Date

21-10-2024

Latest Decision Or Authorization Date

08-11-2024

Processing Time Days

18

Number Of Sites

1

Number Of Participants

210

Germany

Earliest CTIS Part Ii Submission Date

21-10-2024

Latest Decision Or Authorization Date

22-07-2025

Processing Time Days

274

Number Of Sites

2

Number Of Participants

610

Netherlands

Earliest CTIS Part Ii Submission Date

30-03-2026

Latest Decision Or Authorization Date

31-03-2026

Processing Time Days

1

Number Of Sites

1

Number Of Participants

650

Primary sponsor

Full Name

Parnassia Groep B.V.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands