A Study of Quetiapine for the Treatment of Mood Disorders in Adolescents
Condition: Mood Disorders
MeSH terms: Mood Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to obtain preliminary data regarding the effectiveness,
      tolerability, and safety of quetiapine therapy for adolescents who have a mood disorder and
      have at least one parent with bipolar disorder (severe mood swings).
    

Detailed description: 
      Bipolar disorder is a common, life-long, progressive disease that typically begins in
      adolescence or early adulthood and is associated with significant morbidity and mortality
      (Lish et al., 1994). Family studies have shown that offspring of parents with bipolar
      disorder have a 30% chance of developing a mood disorder, while children with both parents
      with a mood disorder (with at least one with bipolar disorder) have a 70% chance of
      developing a mood disorder (Goodwin and Jamison 1990). Indeed, children (< 18 years old) have
      an even greater risk for developing bipolar disorder if they have a parent with the disorder
      (reviewed in Lapalme et al., 1997; DelBello and Geller, 2002; Chang and Steiner, 2003). Since
      the clinical manifestations of bipolar disorder often present early in life and may worsen
      with age, it is imperative that this illness is recognized and treated as readily as
      possible. Bipolar disorder may have a number of prodromal or early-onset presentations that
      do not include syndromal mania. These prodromes may include cyclothymia, dysthymia, and
      subsyndromal manic, depressive, and mixed affective symptoms (Chang et al., 2000, reviewed in
      Lapalme et al., 1997).

      There have been several investigations of divalproex for the treatment of mood symptoms in
      children at familial risk for bipolar disorder (Chang et al., 2002; Findling et al., 2002).
      Chang et al., found a significant reduction in mood symptoms and improvement in overall
      functioning following treatment with divalproex in 23 children who did not have bipolar I
      disorder but who were diagnosed with mood symptoms/syndromes and who had a parent with
      bipolar disorder (Chang et al., 2002). Similarly, Findling et al. reported that children with
      mood symptoms and a multigenerational family history of bipolar disorder had a significant
      reduction in mood symptoms when treated with divalproex compared with placebo (Findling et
      al., 2002). To our knowledge, there have been no studies evaluating the use of atypical
      antipsychotics for the treatment of children at familial risk for developing bipolar disorder
      who are diagnosed with mood disorders other than bipolar I disorder.

      Controlled investigations suggest that quetiapine is effective for the treatment of mania in
      adults and adolescents (Adityanjee and Schulz, 2003; Sachs et al., 2002; DelBello et al.,
      2002). Additionally, quetiapine is particularly well-tolerated and safe in children and
      adolescents (DelBello et al., 2002; Findling, 2003). Our group has reported that children at
      risk for bipolar disorder exhibit neurochemical abnormalities, suggesting neuronal damage may
      occur prior to the onset or early in the course of a mood disorder. Furthermore, recent
      laboratory studies suggest that quetiapine may have neuroprotective properties (Xu et al.,
      2002). Therefore, quetiapine is the ideal choice for the treatment of adolescents at familial
      risk for developing bipolar disorder who are presently exhibiting a mood disorder.
    

Intervention name(s): quetiapine
Intervention type(s): Drug
Intervention description(s): 100mg of quetiapine on day 1 and titrated to a maximum dose of 400mg by day 4, with flexible dosing to 600mg by day 28. The total duration of treatment will be 84 days (12 weeks).
Other intervention name(s): Seroquel
Intervention MeSH terms: Quetiapine Fumarate
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adolescents