NCT00395213 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

March JS, Silva SG, Compton S, Anthony G, DeVeaugh-Geiss J, Califf R, Krishnan R
The Child and Adolescent Psychiatry Trials Network (CAPTN). J Am Acad Child Adolesc Psychiatry. 2004 May;43(5):515-8.
March JS, Silva SG, Compton S, Shapiro M, Califf R, Krishnan R
The case for practical clinical trials in psychiatry. Am J Psychiatry. 2005 May;162(5):836-46.

Antidepressant Safety in Kids (ASK) Study: An Open-label, Prospective, Cohort Study of Antidepressants in Children and Adolescents With Anxiety Disorders, Depressive Disorders, Eating Disorders, or Obsessive-Compulsive Disorder

Details for clinical trial NCT00395213

Clinical trial NCT00395213 - References