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Servier Protocol Code:
CL2-20098-072
Sponsor:
Institut de Recherches Internationales Servier
Clinicaltrials.gov Identifier:
NCT01108393
EudraCT Number:
2009-016713-20
Find a recruiting site
How to participate in this study
If you think you are eligible for this study (see
below), you can identify the location closest to you and contact them directly. If you can’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
eligibility criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Name:
Institut de Recherches Internationales Servier, Département des études cliniques
Phone number:
+33 1 55 72 60 00
The study has 1 location
Study description
The study will evaluate the efficacy of agomelatine compared to placebo on the reduction of Obsessive and Compulsive symptoms after 16 weeks of treatment.
Official title: Efficacy of Agomelatine 25mg/Day (With Possible Increase to 50mg/Day After 8 Weeks of Treatment) Given Orally During 16 Weeks in Patients With Obsessive-Compulsive Disorder. A Randomised, Double-blind, Placebo-controlled, Parallel Groups, International Study
Results
English (USA)Conditions
Obsessive Compulsive Disorder
Interventions / Treatments
The treatment(s) given to the participants in the study.
- Agomelatine A
- Placebo
Other study id numbers
Other identification numbers the study may be known by.
- CL2-20098-072
Eligibility Criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligible age for the study
18 years to 65 years
(Adult, Older Adult)
Sex
Male/FemaleAccepts Healthy Volunteers
No- * Obsessive Compulsive Disorder (OCD) according to Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR),
- * Y-BOCS total score ≥ 20,
- * duration of OCD symptoms of at least one year.
- * Bipolar disorder, Schizophrenic or Psychotic Disorder
- * Severe or uncontrolled organic diseases
- * Neurological disorder
- * Women of childbearing potential who are not using effective contraception
How is the study designed?
Allocation
How participants are assigned to different groups. Allocation can be random (randomized) or predetermined (non-randomized). Randomized means that participants are assigned at random to their participant group / arm.
Interventional study model
How treatments are given and tested in a study.
Parallel
A parallel study design compares two or more groups at the same time, with each group receiving a different treatment. Researchers then compare the results to determine which treatment is more effective.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Experimental:
Agomelatine A
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
Agomelatine A
Agomelatine 25 mg film-coated tablet
Agomelatine 2x25mg film-coated tablet
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Placebo Comparator:
Placebo
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
Placebo
Placebo
Keywords
Provided by Servier
Obsessive Compulsive Disorder
Agomelatine
Additional Relevant MeSH Terms Glioma
Obsessive-Compulsive Disorder