A Study of Bitopertin (RO4917838) in Combination With Selective Serotonin Reuptake Inhibitors (SSRIs) in Participants With Obsessive-Compulsive Disorder (OCD)
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Lead
Hoffmann-La Roche
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Primary diagnosis of OCD as per Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
On a stable dose of SSRI for at least 8 weeks prior to screening an between screening and Day 1
An insufficient response to current treatment with an SSRI given at an adequate dose for at least 12 weeks prior to Day 1
Females who are not postmenopausal or surgically sterile and who have (or may have) male sexual partners must agree to use two adequate methods of contraception as defined by protocol from the start of screening until 90 days after the last dose of study drug
You may not be if
Primary OCD symptom of hoarding
More than two unsatisfactory trials within the last 2 years with different serotonin reuptake inhibitors (not including the current treatment with an SSRI) given in an adequate dose for at least 12 weeks
Failure of more than three augmentation therapies within the last 2 years
Undergoing acute behavioral therapy or having acute behavioral therapy that was completed less than 4 weeks prior to Day 1
Any primary DSM-IV-TR Axis I disorder other than OCD
Current or prior history of bipolar disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, or Gilles de la Tourette syndrome if symptoms have persisted into adulthood
Any eating disorder within the last 6 months
History of DSM-IV-TR-defined substance dependence and/or substance abuse in the last 6 months, with the exception of nicotine
Previous treatment with bitopertin or another Glycine transporter 1 inhibitor
Positive urine drug screening for cannabis, amphetamines (including 3,4-methylenedioxymethamphetamine \[MDMA\]/ecstasy), cocaine, barbiturate, and/or opiates
Prior or current general medical condition that may impair cognition or other neuropsychiatric functioning
Body mass index less than (\<) 18.5 kilogram per square meter (kg/m\^2) or greater than (\>) 40 kg/m\^2
Pregnant or lactating women
Clareo Health | A Study of Bitopertin (RO4917838) in Combination With Selective Serotonin Reuptake Inhibitors (SSRIs) in Participants With Obsessive-Compulsive Disorder (OCD)
