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OpenTrials
Completed

NCT Number: NCT00811473

Pediatric Bipolar Depression

The purpose of this study is to determine if quetiapine fumarate extended-release (quetiapine XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in treating children or adolescents aged 10 to 17 with bipolar depression and if so, how it compares with placebo (a non-active tablet, like a sugar pill, that looks like quetiapine).

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Key information

Conditions

Bipolar Depression Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Depression Mental Disorders Mood Disorders

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Bogota D.c, Cundinamarca, Colombia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of informed consent by one or both parents or legal guardian and written assent by the patients before any study procedures are performed.
  • The patient must have a documented clinical diagnosis for bipolar I or bipolar II disorder, and including current episode depressed.
  • Patients are required to be in outpatient status at the enrollment and randomization visits and believed likely to remain an outpatient for the duration of the study.
  • Patients must be able to swallow the study medication tablets.

Exclusion criteria

  • The patient must not have been diagnosed with Tourette's Disorder, Obsessive-Compulsive Disorder, acute Post-traumatic Stress Disorder, Panic Disorder, Autistic Disorder and/or Asperger's Disorder.
  • Patient can not have a history of non-response to an adequate treatment to more than 2 antidepressants during the current episode.
  • The patient must not have received electroconvulsive therapy (ECT) within 30 days before participating in the study.
  • Patients who in your doctors judgement pose a current suicidal or homicidal risk.

Treatment and study plan

Quetiapine XR

Drug

Oral treatment with 150 up to 300 mg/day once daily in the evening

Other names: Seroquel XR

Placebo

Drug

Oral treatment once daily in the evening

Primary outcomes

  1. Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57)

    Time frame: Will be scored at all visits. the analysis is the change from baseline to the final assessment at day 57

    Severity of depression in children and adolescents was calculated based on the 17-item CDRS-R scale (3 items scored from 1-5 and 14 items scored from 1-7, with higher scores indicating more severe depression). The 17 item scores are summed to give the total score (total score range 17-113).

Secondary outcomes

  1. Number of Patients Reaching Remission Where Remission is Defined as CDRS-R Total Score ≤28 at Final Assessment (Day 57).

    Time frame: Days 8 to 57

    The number of patients with remission from Days 8 to 57 was calculated. The CDRS-R is a 17-item scale with 3 items scored from 1-5 and 14 items scored from 1-7, where higher scores indicating more severe depression. The 17 item scores are summed to give the total score (total score range 17-113).

  2. The Number of Patients With the Response, Where Response is Defined as ≥50% Reduction From Baseline to Final Assessment (Day 57) in CDRS-R Total Score

    Time frame: Days 8 to 57

    The number of patients reaching response from Days 8 to 57 was calculated. The CDRS-R is a 17-item scale with 3 items scored from 1-5 and 14 items scored from 1-7, where higher scores indicating more severe depression. The 17 item scores are summed to give the total score (total score range 17-113).

  3. Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S

    Time frame: Change from Baseline to Day 57

    The CGI-BP-S scale rates the severity of the patient's illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity.

  4. CGI-BP-C Score at Final Assessment (Day 57)

    Time frame: Change from Baseline to day 57

    The CGI-BP-C scale rates how much the patient's illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). CGI-BP-C scores >4 indicate worsening, while scores <4 indicate improvement.

  5. The Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness

    Time frame: Day 57

    The proportion of patients with improvement of overall bipolar illness at Day 57 was calculated. Improvement defined as a CGI-BP-C of "Much" or "Very much" improved in overall bipolar illness assessment.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An 8-week, Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended-Release in Children and Adolescent Subjects With Bipolar Depression

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 19, 2008
Registry last updated
Jul 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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