psychiatrische en obsessieve en compulsieve stoornissen Obsessive Compulsive Disorder
Conditions
Interventions
4 bloodsamples will be taken during the study for haematology and biochemistry
(at selection, W8,W12,W16). The total amount will not exceed 60ml. An ECG
needs to be performed during selection or inc
Sponsors
Servier R&D Benelux
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Out patients, male or female, between 18 and 65 years inclusive with a primary diagnosis of Obsessive Compulsive Disorder (OCD) according to DSM-IV-TR. The diagnosis will be documented by the brief structured interview M.I.N.I. - Patients previously treated for OCD with a first line pharmacological treatment, i.e, SRI with or without cognitive behavioural therapy . - Y-BOCS total score * 20 (moderately to severely ill), - Duration of OCD symptoms of at least one year, - Requiring a treatment.
Exclusion criteria
Exclusion criteria: cfr p. 25-26 - Episodic OCD, Exclusive hoarders, Early onset OCD - Refractory patients defined as having not responded to 2 or more adequate treatments (medium or high) dose of a SRI for at least 12 weeks. - Patients in psychiatric care for more than 5 years for OCD - Naïve Patients (never received pharmacological treatment for OCD) - Motor or verbal tic disorder (including Tourette*s), - Substance or alcohol dependence or abuse - personality disorders - Severe or uncontrolled organic diseases, likely to interfere with the conduct of the study (e.g., neurologic, neoplasic, cardiovascular, pulmonary, digestive or metabolic disorders like unstabilized diabetes of type I or II, morbid obesity, untreated or uncontrolled arterial hypertension*), - Any clinically relevant abnormality detected during the physical examination, ECG or laboratory tests likely to interfere with the study conduct or evaluation, - Hepatic impairment (i.e. cirrhosis or active liver disease), - ASAT or ALAT values * 2 times the upper reference value - Total bilirubin * 2 times the upper reference value or ALAT and total bilirubin >ULN - Alkaline Phosphatase * 3 times the upper reference value, - Women of childbearing potential without effective contraception (oral contraceptive pill, Intra-uterine contraceptive device or condom) as well as - pregnant or breastfeeding women - Concomitant psychotropic medications are forbidden during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Y-BOCS total score (expressed as the change from baseline to last post-baseline value on W0-W16 period) will be used to demonstrate the superiority of agomelatine compared to placebo on OC symptoms. | — |
Secondary
| Measure | Time frame |
|---|---|
| - National Institute of Mental Health-Obsessive-Compulsive Scale score (NIMH-OC) - CGI Severity of Illness and Global Improvement scores - Obsessive Compulsive Visual Aanalogue Scale (OC-VAS) - Montgomery and Asberg depression rating scale (MADRS) total score - Hamilton Rating Scale for Anxiety (HAM-A) total score - Getting off to sleep score, Quality of sleep score, Sleep awakening score and Integrity of behaviour score obtained from the Leeds Sleep Evaluation Questionnaire (LSEQ). - Work, Social life and Family life scores obtained from Sheehan disability scale - Adverse events - Sitting blood pressure (SBP (mmHg) and DBP (mmHg)) and heart rate (bpm). - Body weight (kg) and BMI (kg/m²). - Laboratory parameters. | — |
Countries
Netherlands
Outcome results
None listed