Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-24 @ 1:03 PM
NCT ID:
NCT01428661
Eligibility Criteria:
Inclusion Criteria:
* Subjects with diagnosis of MDD, single or recurrent episode, according to DSM-IV TR criteria;
* Current episode ≥4 weeks and ≤1 year;
* CGI-Severity score ≥4 at screening and baseline.
Exclusion Criteria:
* Lifetime history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive-compulsive disorder;
* Any other current Axis I (except general anxiety disorder as long as it is not considered the primary disorder) or Axis II disorder;
* A positive test for drugs of abuse at the screening visit and/or history of drug or alcohol abuse/dependence as defined in DSM-IV TR, Diagnostic Criteria for Drug and Alcohol Abuse and Dependence, within the past 12 months;
* Formal psychotherapy within 3 months of the screening visit. General supportive psychotherapy is acceptable;
* Participation in a previous tasimelteon trial. Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01428661
Study Brief:
Protocol Section:
NCT01428661