Mechanism of Antidepressant-Related Dysfunctional Arousal in High-Risk Youth
Trial ID or NCT#
NCT02553161
Status
NOT RECRUITING
Purpose
A 16-week double blind, placebo-controlled investigation of escitalopram in adolescents with depression and/or anxiety with a family history of Bipolar Disorder. Subjects will be evaluated using semi-structured diagnostic interviews and symptom ratings, participate in a MRI scan and then randomized to treatment. Following randomization, high-risk youth will have visits every week for the first 4 weeks of treatment then biweekly up to 16 weeks during which time tolerability and ratings will be performed. MRI scan will be repeated at week 4.
Official Title
Mechanism of Antidepressant-Related Dysfunctional Arousal in High-Risk Youth
Eligibility Criteria
Ages Eligible for Study: 12 Years to 17 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
- Inclusion - High-Risk Youth: 1. age 12 years, 0 mos. - 17 years, 11 mos.; 2. at least one parent or step-parent/guardian with whom the subject lives is willing to participate in research sessions; 3. the child and relative(s) are able and willing to give written informed assent/consent to participate, respectively; 4. the youth meets criteria for high-risk: - has at least one first degree relative with Bipolar I Disorder, as assessed by the Structured Clinical Interview for DSM (SCID; First et al. 1995), the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-PL, Kaufman et al., 1997), and the Family History-Research Diagnostic Criteria (FH-RDC; Andreasen et al., 1977); - the youth shows evidence of current significant depressive or anxiety symptoms as determined by a current Childhood Depression Rating Scale-Revised (CDRS-R, Poznanski et al.,1984) score > 35 and/or a current Pediatric Anxiety Rating Scale (PARS, 2002) score > 15. Inclusion - Healthy Controls: 1. age 12 years, 0 mos. - 17 years, 11 mos.; 2. at least one parent or step-parent/guardian with whom the subject lives is willing to participate in research sessions; 3. the child and relative(s) are able and willing to give written informed assent/consent to participate, respectively; 4. no personal or family history of any psychopathology as assessed by the KSADS-PL structured clinical interview (Kaufman et al., 1997) and the Family History-Research Diagnostic Criteria (FH-RDC; Andreasen et al., 1977).
Exclusion Criteria:
- Exclusion - High-Risk Youth & Healthy Controls: 1. any history of syndromal bipolar I or II disorder (i.e., history of mania, mixed episode, or major depression with hypomania); 2. a history of previous antidepressant exposure 3. a DSM-5 diagnosis of autism, pervasive developmental disorder, OCD(Obsessive-Compulsive Disorder), PTSD, Tourette's disorder, or any psychotic disorder including schizophrenia; 4. evidence of mental retardation (IQ < 70) as determined by the Weschler Abbreviated Scale of Intelligence (WASI; Psychological Corporation, 1999); 5. comorbid neurologic diseases such as seizure disorder; 6. Drug or alcohol abuse or dependence disorders in the 4 months prior to study recruitment, although a lifetime history of substance or alcohol disorders can be present if the child has been abstinent for at least 6 months (see further discussion below); 7. evidence of an unstable medical or psychiatric disorder that requires immediate hospitalization or other emergency medical treatment; 8. a positive pregnancy test; participants will be encouraged but not mandated to discuss a positive pregnancy test with their guardians and we will follow local laws. 9. any contraindication for MRI, including metal in the body related to an injury or surgery (e.g., surgical clips, metal fragments in the eyes), piercings that cannot be removed, braces, or permanent retainers.
Investigator(s)
Kyle Hinman, M.D.
Psychiatrist
Clinical Assistant Professor, Psychiatry and Behavioral Sciences - Child & Adolescent Psychiatry and Child Development
Contact us to find out if this trial is right for you.
Contact
Manpreet K Singh, MD MS
650-725-5922
View on ClinicalTrials.gov
