Proof of concept study to evaluate the effect of AFQ056 in obsessive compulsive disorder (OCD) patients resistant to Selective Serotonin Reuptake Inhibitor (SSRI) therapy
- Conditions
- Therapeutic area: Diseases [C] - Nervous System Diseases [C10]obsessive compulsive disorder (OCD)MedDRA version: 12.0Level: HLTClassification code 10002862Term: Anxiety disorders NEC (incl obsessive compulsive disorder)System Organ Class: 100000004873
- Registration Number
- EUCTR2012-005000-17-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
Patients eligible for inclusion in this study have to fulfill all of the
following criteria:
1. Male and female, non-smokers patients aged between 18 to 65 years
(inclusive),
2. A primary diagnosis of obsessive-compulsive disorder (OCD) as per
Diagnostic and
Statistical Manual of Mental Disorders (DSM-IV-TR 4th ed, year 2000), as
confirmed by
an Independent Rater.
3. Be on a stable appropriate dose of selective serotonin reuptake
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inhibitor (SSRI) treatment for at least 12 weeks prior to Baseline.
4. Have an insufficient response to current SSRI treatment (as per
Inclusion Criterion 4) and confirmed by an Independent Rater.
Note: Treatment with SSRI and related time period must be documented
in the medical records of the patient (e.g. former prescription, former
medical records). Note that
patient self report is not acceptable.
5. Have a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) of score = 16 at Screening (and confirmed by an Independent Rater).
6. Patient must have their eligibility confirmed following the remote (or
face to face)
interview conducted by the Independent Rater.
7. Able to communicate well with the investigator, to understand and comply with the requirements of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
inclusion in this study:
1. Diagnosis of primary OCD symptom of hoarding.
2. History of more than two unsatisfactory trials with different serotonin reuptake inhibitors within a period of 2 years prior to screening (not including the current treatment with SSRI's given in an adequate dose for at least 12 weeks).
3. Diagnosed with any primary DSM-IV-TR Axis I disorder other than OCD (as confirmed by an Independent Rater); with the exception of depression (refer to criterion 5).
4. History eating disorder according to DSM-IV within the last 6 months prior to Screening
5. Diagnosed with antisocial personality disorder (DSM-IV-TR Axis II), as confirmed by an Independent Rater.
6. Has current or past medical history of bipolar disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism (with exception of high-functioning or autistic spectrum disorders e.g. Asperger’s Syndrome), borderline personality disorder
7. Smokers (use of tobacco products in the previous 3 months)
8. History (lifetime) of hallucinations/psychosis that would require
antipsychotic treatment or DSM-IV criteria being met
9. Score yes on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or yes on any item of the Suicidal Behavior section, except for the Non-Suicidal Self- Injurious Behavior (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years.
10. Women of child-bearing potential, defined as all women
physiologically capable of becoming pregnant, unless they are using
effective methods of contraception during dosing and for 30 days
after last dosing of study medication.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method