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Sponsors and Collaborators: |
University of Cincinnati AstraZeneca |
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Information provided by: | University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT00221468 |
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).
Condition | Intervention | Phase |
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Mood Disorders |
Drug: quetiapine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Single Blind, Dose Comparison, Single Group Assignment |
Official Title: | A Single-Blind Prospective Study of Quetiapine for the Treatment of Mood Disorders in Adolescents |
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.
Ages Eligible for Study: | 12 Years to 18 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
To be included in this study, subjects must meet the following criteria:
Exclusion Criteria:
Patients will be excluded from the protocol for any of the following reasons:
United States, Ohio | |
University of Cincinnati Medical Center | |
Cincinnati, Ohio, United States, 45267 |
Principal Investigator: | Melissa P DelBello, MD | University of Cincinnati |
Study ID Numbers: | IRUSQUET0296 |
Study First Received: | September 15, 2005 |
Last Updated: | March 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00221468 History of Changes |
Health Authority: | United States: Institutional Review Board |
Adolescents |
Quetiapine Tranquilizing Agents Mental Disorders Psychotropic Drugs |
Mood Disorders Central Nervous System Depressants Antipsychotic Agents |
Disease Tranquilizing Agents Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Pharmacologic Actions |
Quetiapine Pathologic Processes Mental Disorders Therapeutic Uses Mood Disorders Central Nervous System Agents |