Child and Adolescent Depression Study (Roswell)
This 10 week study is for patients 12-17 years old examining the safety and efficacy of Vilazodone. Patients need to have been experiencing depression for at least 6 weeks.
- Patients must give assent and have an LAR/caregiver who gives consent.
- Patients must meet DSM-IV-TR criteria for MDD with a minimum duration of 6 weeks at Visit 1.
- Patients must not have another current principal DSM-IV-TR-based diagnosis of an Axis I disorder other than MDD that is the primary focus of treatment. Patients with comorbid diagnoses of learning disorders, ADD, communication disorders, separation anxiety disorder, dysthymic disorder, oppositional defiant disorder, and anxiety disorders may participate, as long as they are not the primary focus of treatment.
- Patients with mental retardation, amnesic or other cognitive based disorders may not participate
- If the patient is at imminent risk of injuring self, others or property, they may not participate.
- Patients who have attempted suicide within the past year, or have significant risk of doing so may not participate
- Certain medications and health conditions are excluded. Please see the coordinator for specifics.
Children and Adolescent Depression Study (Marietta)
This study is examining the efficacy of Dexvenlafaxine Succinate sustained-release in children between the ages of 7 to 11. The study will last approximately 17 weeks, with 10 visits.
- Patient meets diagnostic criteria for MDD without psychotic features of moderate severity with symptoms lasting at least a month before screening.
- MDD that could respond to therapy with ADT alone without the need for concomitant psychotherapy
- The patient cannot have experienced a major illness within 90 days prior to screening
- Patients who have suicidal ideation associated with actual intent and/or plan or an actual suicide attempt at any time in their lifetime may not participate. Patients who have had a first degree relative commit suicide are also excluded.
- Patients with a history of failure to respond to an adequate course of treatment for MDD with Effexor or Pristiq may not participate
- Patient cannot meet the criteria for bipolar disorder, PTSD, OCD, anorexia, bulimia, or alcohol abuse or dependence.
- Patients cannot participate if they have GAD, panic disorder, borderline personality or other personality disorder, or ADHD as a primary diagnosis.
- Patients must be able to swallow tablets whole without chewing or crushing.