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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Melissa Delbello, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00232414
First received: September 30, 2005
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Bipolar I Disorder
Drug: Quetiapine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind Randomized Placebo Controlled Study of Quetiapine for the Treatment of Depression in Adolescents With Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

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

Secondary Outcome Measures:
  • Secondary Efficacy Measures
  • CDRS response rate: Defined by a > 50% decrease from baseline to endpoint in CDRS total score.
  • 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)
  • Hamilton Anxiety Rating Scale (HAM-A): Measure of efficacy will be change from baseline to endpoint in HAM-A
  • Safety
  • Proportion of patients who met criteria for treatment-emergent mania (YMRS score > 16 on two consecutive visits or at final assessment).
  • Incidence of adverse events
  • Incidence of EPS (as measured by change from baseline to endpoint in EPS rating scales)
  • Change from baseline to endpoint in all laboratory measures and vital signs.

Estimated Enrollment: 30
Study Start Date: October 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00232414

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

No publications provided

Responsible Party: Melissa Delbello, Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00232414     History of Changes
Other Study ID Numbers: IRUSQUET0384
Study First Received: September 30, 2005
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
bipolar
with acute depressive episode

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 17, 2014