PMC:4235387 / 8271-9615 JSONTXT

{"project":"NEUROSES","denotations":[{"id":"T182","span":{"begin":93,"end":97},"obj":"CHEBI_25016"},{"id":"T183","span":{"begin":503,"end":507},"obj":"CHEBI_25016"},{"id":"T184","span":{"begin":1047,"end":1051},"obj":"CHEBI_25016"},{"id":"T185","span":{"begin":93,"end":97},"obj":"CHEBI_27889"},{"id":"T186","span":{"begin":503,"end":507},"obj":"CHEBI_27889"},{"id":"T187","span":{"begin":1047,"end":1051},"obj":"CHEBI_27889"},{"id":"T188","span":{"begin":234,"end":243},"obj":"PATO_0001632"},{"id":"T189","span":{"begin":315,"end":318},"obj":"CHEBI_566274"},{"id":"T190","span":{"begin":725,"end":731},"obj":"PATO_0002354"},{"id":"T191","span":{"begin":1295,"end":1300},"obj":"PATO_0000389"}],"text":"Study participants\nInclusion criteria for the study included the completion of either of the lead-in trials immediately before enrollment in the extension study. The baseline visit must have been the same day as the completion of the preceding study. Study participants were required to have a primary diagnosis of MDD (classification code 296.xx) as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision (American Psychiatric Association, 2000) at entry into the lead-in study and a clinical indication (in the opinion of the investigator) for 12 months of continued treatment. Study participants were required to be able to understand and comply with study instructions, and sexually active study participants of child-bearing potential had to agree to use appropriate contraception during the study and for 1 month afterward. Exclusion criteria included any concomitant diagnosis of other psychiatric disorders (e.g. mania, bipolar disorder, schizophrenia, etc.) before or during entry into either of the lead-in studies, risk for suicide, and/or a score of at least 5 points on item 10 (suicidal thoughts) on the MADRS. Study participants were also excluded if they experienced a continuing moderate or severe AE related to treatment from the original acute trial or were using disallowed medications."}