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 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT01491035
Eligibility Criteria:
Inclusion Criteria:
* Patients with a DSM-IV-TR diagnosis of Depressive or Anxiety Disorder.
* The patient and parent(s)/legal representative(s) are able to comprehend and satisfactorily comply with the protocol requirements.
* Treatment with antidepressant therapy is warranted, as judged by the investigator.
Exclusion Criteria:
* The patient is pregnant or breast-feeding.
* The patient presents or has a history of an Axis I (DSM-IV-TR) diagnosis of Bipolar Disorder, Post Traumatic Stress Disorder (PTSD), Autism, Pervasive Developmental Disorder (PDD), Obsessive Compulsive Disorder (OCD) or Schizophrenia or Schizoaffective Disorder.
* The patient has not maintained a stable dose of a methylphenidate or amphetamine for their treatment of attention-deficit/hyperactivity disorder (ADHD) for a minimum of 4 weeks prior to the study treatment.
* The patient has a known mental retardation, or clinical evidence or known social or school history indicative of mental retardation.
* The patient is at significant risk of committing suicide based on history (for example previous suicide attempt) or according to the investigator's experience, or based on active suicidal ideation, intent or plan, item 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS).
* The subject has any concurrent illness that may affect the particular target or absorption, distribution, and elimination of the investigational medicinal product (IMP).
* The patient meets DSM-IV-TR criteria for any psychoactive substance or alcohol use disorder.
Other inclusion and exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
17 Years
Study:
NCT01491035
Study Brief:
Protocol Section:
NCT01491035