A Double-Blind Randomized Placebo Controlled Study of Quetiapine for the Treatment of Depression in Adolescents With Bipolar Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00232414
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : December 10, 2013
Information provided by (Responsible Party):
Melissa Delbello, University of Cincinnati

Brief Summary:

In this study, quetiapine is being tested for the possible treatment of bipolar I disorder with an acute depressive episode in children and adolescents.

We hypothesize that quetiapine will be more efficacious than placebo for the treatment of episodes of major depression associated with adolescent BP. Moreover, we hypothesize that quetiapine will be safe and well-tolerated compared with placebo for the treatment of depression associated with adolescent BP. Based on data from the BOLDER study and other studies of atypical antipsychotics in patients with bipolar depression (Calabrese et al., 2004, Macfadden et al., 2004, Tohen et al., 2004), which in general reveal effect sizes of approximately 0.5, a conservative sample size calculation, assuming power of .8, estimates we would need approximately 15 patients in each group to identify a statistically significant group difference in our main outcome measure, change form baseline to endpoint in the Children's Depression Rating Scale (Poznanski, 1979).

Condition or disease Intervention/treatment Phase
Bipolar I Disorder Drug: Quetiapine Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind Randomized Placebo Controlled Study of Quetiapine for the Treatment of Depression in Adolescents With Bipolar Disorder
Study Start Date : October 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Primary Outcome Measures :
  1. Children's Depression Rating Scale (CDRS): Measure of efficacy will be a change in CDRS total scores from baseline endpoint.

Secondary Outcome Measures :
  1. Secondary Efficacy Measures
  2. CDRS response rate: Defined by a > 50% decrease from baseline to endpoint in CDRS total score.
  3. Clinical Global Impression Improvement Scale BP Version (CGI-I BP) Improvement Score response rate: Defined by an endpoint CGI-I score of 1 or 2 (much or very much improved)
  4. Hamilton Anxiety Rating Scale (HAM-A): Measure of efficacy will be change from baseline to endpoint in HAM-A
  5. Safety
  6. Proportion of patients who met criteria for treatment-emergent mania (YMRS score > 16 on two consecutive visits or at final assessment).
  7. Incidence of adverse events
  8. Incidence of EPS (as measured by change from baseline to endpoint in EPS rating scales)
  9. Change from baseline to endpoint in all laboratory measures and vital signs.

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

To be included in this study, subjects must meet the following criteria:

  1. Male or female patients, 12-18 years of age.
  2. Female patients of menarche must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence).
  3. Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation.
  4. Patients must have a diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) BP, type I and currently display an acute depressive episode as determined by K-SADS (Geller et al 2000).
  5. Patients must have a baseline (day 0) CDRS score of at least 40.
  6. Subjects should be fluent in English.

Exclusion Criteria:

Patients will be excluded from the protocol for any of the following reasons:

  1. Female patients who are either pregnant or lactating.
  2. Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions.
  3. Any history of current or past diabetes that was treated with pharmacological intervention.
  4. Neurological disorders including epilepsy, stroke, or severe head trauma.
  5. Clinically significant laboratory abnormalities, on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, lipid profile, fasting glucose, urinalysis, thyroid indices and EKG.
  6. Depression due to a general medical condition or substance-induced depression (DSM-IV).
  7. Mental retardation (IQ <70).
  8. YMRS score of > 12.
  9. History of hypersensitivity to or intolerance of quetiapine.
  10. Prior history of quetiapine non-response.
  11. DSM-IV substance (except nicotine or caffeine) dependence within the past 3 months.
  12. Judged clinically to be at suicidal risk (defined as having active suicidal ideation, intent or plan, or a serious suicide attempt within 30 days, or a baseline CDRS suicide score of > 3).
  13. Participation in a clinical trial of another investigational drug within 1 month (30 days) prior to study entry.
  14. Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0.
  15. Treatment with concurrent mood stabilizers or anticonvulsants, benzodiazepines (except as described below), psychostimulants, guanethidine, or guanadrel, or antidepressants.
  16. Patient who were treated with carbamazepine at any point during the month prior to screening.
  17. Schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV.
  18. Major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified.
  19. Subjects who are not fluent in English.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00232414

United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0559
Sponsors and Collaborators
University of Cincinnati
Principal Investigator: Melissa DelBello, MD University of Cincinnati and Cincinnati Children's Hospital

Responsible Party: Melissa Delbello, Professor, University of Cincinnati Identifier: NCT00232414     History of Changes
Other Study ID Numbers: IRUSQUET0384
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2013

Keywords provided by Melissa Delbello, University of Cincinnati:
with acute depressive episode

Additional relevant MeSH terms:
Bipolar Disorder
Pathologic Processes
Behavioral Symptoms
Bipolar and Related Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs