Trial Search Results

Mechanism of Antidepressant-Related Dysfunctional Arousal in High-Risk Youth

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

University of Cincinnati

Collaborator: National Institute of Mental Health (NIMH)

Stanford Investigator(s):

Intervention(s):

  • Drug: Escitalopram
  • Behavioral: Cognitive behavioral Psychotherapy

Phase:

N/A

Eligibility


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.

Ages Eligible for Study

12 Years - 17 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Manpreet K Singh, MD MS
650-725-5922
Recruiting