Adolescents with Depression and/or Anxiety and a Parent or Sibling with Bipolar Disorder

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    Recruiting
Updated on 25 March 2021

Summary

Adolescents with Depression and/or Anxiety and a Parent or Sibling with Bipolar Disorder

Description

The purpose of this research study is to investigate brain changes in adolescents who are currently experiencing depressive and/or anxiety symptoms and have a family history of bipolar disorder. Participants will be randomized to escitalopram and psychotherapy or placebo and psychotherapy for 16-week treatment.

Participants will receive compensation for their transportation and/or time for the study visits. All study visits, tests, procedures and medication will be provided at no cost to participants. Participants will have MRI scans.

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.

Details
Condition Attention Deficit/Hyperactivity Disorder (ADHD - Pediatric), Bipolar Disorder, Bipolar Disorders (Pediatric)
Clinical Study IdentifierTX144530
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Inclusion - High-Risk Youth
age 12 years, 0 mos. - 17 years, 11 mos
at least one parent or step-parent/guardian with whom the subject lives is willing to participate in research sessions
the child and relative(s) are able and willing to give written informed assent/consent to participate, respectively
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
age 12 years, 0 mos. - 17 years, 11 mos
at least one parent or step-parent/guardian with whom the subject lives is willing to participate in research sessions
the child and relative(s) are able and willing to give written informed assent/consent to participate, respectively
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
any history of syndromal bipolar I or II disorder (i.e., history of mania, mixed episode, or major depression with hypomania)
a history of previous antidepressant exposure
a DSM-5 diagnosis of autism, pervasive developmental disorder, OCD(Obsessive-Compulsive Disorder), PTSD, Tourette's disorder, or any psychotic disorder including schizophrenia
evidence of mental retardation (IQ < 70) as determined by the Weschler Abbreviated Scale of Intelligence (WASI; Psychological Corporation, 1999)
comorbid neurologic diseases such as seizure disorder
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)
evidence of an unstable medical or psychiatric disorder that requires immediate hospitalization or other emergency medical treatment
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
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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