Ecopipam Treatment of Tourette's Syndrome in Subjects 7-17 Years

Exclusion Criteria

• •Subjects who have unstable medical illness or clinically significant abnormalities on laboratory tests, or ECG at Screening.
• •Subjects with a major depressive episode in the past 2 years
• •Subjects with a history of attempted suicide
• •Subjects with clinically significant suicidality (based on the Columbia Suicide Rating Scale (C-SSRS)
• •Subjects with a first-degree relative with a major depressive episode that resulted in any psychiatric hospitalization, or attempted/ completed suicide with the exception of a hospitalization for post-partum depression.
• •Subjects with a history of seizures (excluding febrile seizures that occurred \>2 years in the past)
• •Subjects with a myocardial infarction within 6 months.
• •Girls who are currently pregnant or lactating.
• •Subjects who have a need for medication (other than ecopipam) with possible effects on TS symptoms (i.e., lithium, psychostimulants)
• •Subjects who have a need for medications which would have unfavorable interactions with ecopipam, e.g., dopamine antagonists or agonists \[including bupropion\], tetrabenazine, or monoamine oxidase inhibitors.
• •Subjects with a lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any psychotic disorder determined by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) Axis-I Disorders (SCID).
• •Subjects with current or recent (past 3 months) DSM-IV substance abuse or dependence (with the exception of nicotine).
• •Subjects with positive urine drug screen (cocaine, amphetamine, methamphetamine, tetrahydrocannabinol (THC), benzodiazepines, barbiturates, phencyclidine (PCP), opiates) at Screening. Subjects with urine positive only for benzodiazepines and/or marijuana (i.e., a user but not an abuser as based on DSM-IV criteria) may be eligible.
• •Subjects who have had previous treatment with ecopipam.
• •Subjects who have had treatment with:
• •* investigational medication within 3 months of starting study
• •* depot neuroleptics within 3 months of starting study
• •* other psychotropics with possible effects on TS symptoms (i.e., lithium, tetrabenazine) within 2 weeks prior to Screening.
• •* oral neuroleptics within 4 weeks
• •* selective serotonin reuptake inhibitors unless the dosage has been stable for a minimum of 4 weeks prior to study start and not prescribed to relieve the neurological signs of TS