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Therapeutic Areas: Psychiatry/Psychology
Disease Category: Depression (Adolescent)

Trial Information

Multicenter, open-label, safety, tolerability, and pharmacokinetic study to evaluate single ascending doses and subsequent short-term administration of fixed doses of Desvenlafaxine succinate sustained-release tablets in the treatment of adolescent outpatients with Major Depressive Disorder

The main purpose of this study is to find out if desvenlafaxine (DVS SR) is safe for adolescents and if it helps to relieve their symptoms of depression. This study will also learn how DVS SR is broken down in one's body through blood analysis tests called pharmacokinetic (PK) tests. DVS SR, also called Pristiq®, was recently approved by the FDA to treat adults with MDD, but has not been studied in adolescents. Therefore, we do not know if it works to treat adolescents with depression, and this study is to test this possibility. The study will last up to 13 weeks, and will consist of a screening period of about six to 14 days to see if the study is appropriate for your adolescent, an inpatient period of 3.5 days where your adolescent will begin the study treatment and be monitored for his/her reaction to the study medication, an outpatient period of 7.5 weeks where your adolescent will continue study treatment daily from home, and a taper/follow-up period of up to three weeks to gradually stop the medication. During the treatment period, there will be three doses of the study medication, 25, 50, or 100 mg. Your child will be assigned to one of these doses and will stay on the same dose throughout the study. You, your adolescent, and the study doctor will know the dose that your adolescent is receiving. Transportation expenses will be reimbursed. Additionally, all participants will receive three months of standard treatment for MDD as follow-up at no cost to you.

Patient Inclusion Criteria

• Able to understand study and follow study procedures
• Children and adolescents ages of 12-17 who are in good physical health
• All sexually active participants of childbearing potential who are using a medically acceptable form of birth control and condoms
• Diagnosis of MDD or ongoing symptoms for at least one month
• Able to participate as an inpatient for first four days of study

Patient Exclusion Criteria

• Medical conditions that would conflict with participation.
• Psychiatric disorders or symptoms that would conflict with participation
• Participants who have attempted suicide or experienced thoughts of suicide
• Using medications prohibited in study
• Receiving psychotherapy for MDD
• Females who are pregnant or nursing, or who plan to become pregnant