and Resistant to SSRI Treatment (Failed SSRI Over 12 Weeks at Appropriate Doses). Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Parallel-group Proof of Concept Study to Evaluate the Effect of AFQ056 in Obsessive Compulsive Disorder (OCD) Patients Resistant to Selective Serotonin Reuptake Inhibitor (SSRI) Therapy
| Verified date | April 2015 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to determine whether AFQ056 as an add on therapy to SSRIs can have beneficial effects by reducing the total score of Y-BOCS (Yale and Brown Obsessive Compulsive Scale) in OCD patients resistant to SSRI treatment (failed SSRI over 12 weeks at appropriate doses).
| Status | Completed |
| Enrollment | 33 |
| Est. completion date | November 2014 |
| Est. primary completion date | November 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Male and female , non-smokers patients aged between 18 to 65 years (inclusive), - 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. - Be on a stable appropriate dose of selective serotonin reuptake inhibitor (SSRI) treatment for at least 12 weeks prior to Baseline. - Have an insufficient response to current SSRI treatment (as per Inclusion Criterion 4) and confirmed by an Independent Rater. - Have a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) of score = 16 at Screening (and confirmed by an Independent Rater). - Patient must have their eligibility confirmed following the remote interview conducted by the Independent Rater. - Able to communicate well with the investigator, to understand and comply with the requirements of the study. Exclusion Criteria: - Diagnosis of primary OCD symptom of hoarding. - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception (not including oral contraceptives) during dosing and for 30 days after last dosing of study medication. - History of more than two unsatisfactory trials with different SSRI 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). - Diagnosed with any primary DSM-IV-TR Axis I disorder other than OCD (as confirmed by an Independent Rater); with the exception of depression. - History of eating disorder (e.g. anorexia, bulimia) according to DSMIV within the last 6 months prior to Screening, (as confirmed by an Independent Rater). - Diagnosed with antisocial personality disorder (DSM-IV-TR Axis II), as confirmed by an Independent Rater. - Has current or past medical history of bipolar disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, within the last 6 months prior to Screening. - Smokers (use of tobacco products in the previous 3 months). - History of hallucinations/psychosis that would require antipsychotic treatment or DSM-IV criteria being met - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Novartis Investigative Site | Burgas | |
| Bulgaria | Novartis Investigative Site | Pazardzhik | |
| Bulgaria | Novartis Investigative Site | Sofia | |
| Bulgaria | Novartis Investigative Site | Sofia | |
| Bulgaria | Novartis Investigative Site | Varna | |
| Czech Republic | Novartis Investigative Site | Olomouc | Czech Rep. |
| Czech Republic | Novartis Investigative Site | Praha 10 | |
| Czech Republic | Novartis Investigative Site | Strakonice | |
| Czech Republic | Novartis Investigative Site | Ústí nad Labem | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Freiburg | |
| Germany | Novartis Investigative Site | Muenchen | |
| Germany | Novartis Investigative Site | Nürnberg | |
| Germany | Novartis Investigative Site | Ulm | |
| Poland | Novartis Investigative Site | Gdansk | |
| Poland | Novartis Investigative Site | Lodz | |
| Poland | Novartis Investigative Site | Lublin | |
| Poland | Novartis Investigative Site | Torun | |
| Poland | Novartis Investigative Site | Warsaw | |
| Poland | Novartis Investigative Site | Warszawa | |
| Switzerland | Novartis Investigative Site | Bern | |
| Switzerland | Novartis Investigative Site | Zürich | |
| United Kingdom | Novartis Investigative Site | London | |
| United Kingdom | Novartis Investigative Site | Sheffield | South Yorkshire |
| United Kingdom | Novartis Investigative Site | Warrington | |
| United States | Novartis Investigative Site | Brooklyn | New York |
| United States | Novartis Investigative Site | San Diego | California |
| United States | Novartis Investigative Site | Watertown | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Bulgaria, Czech Republic, Germany, Poland, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Y-BOCS absolute change from baseline | Absolute changes from baseline for Y-BOCS will be the primary measure of efficacy in this study. The primary interest will be at week 17 (end of 16-week dosing). | 16 weeks | Yes |
| Secondary | Y-BOCS reduction in total score from Baseline | If a subject demonstrates at least 25% reduction in total Y-BOCS from Baseline then they will be classed as a responder whereas if a subject has a reduction in Y-BOCS of less than 25% then they will be categorized as a nonresponder. | 16 weeks | Yes |