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Mood DisordersPhase 3NCT00221468

A Study of Quetiapine for the Treatment of Mood Disorders in Adolescents

A Phase 3 study testing quetiapine in people with Mood Disorders, run by University of Cincinnati at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Mood Disorders
What is being tested?
quetiapine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Jun 2003to Apr 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • To be included in this study, subjects must meet the following criteria:
  • Male or female patients, 12-18 years of age.
  • Female patients of menarche must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence).
  • 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.
  • Patients must have a diagnosis of a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) mood disorder (dysthymia, major depressive disorder, depressive disorder not otherwise specified, cyclothymic, bipolar I disorder, bipolar II disorder, or bipolar disorder not otherwise specified) as determined by the Washington University at St. Louis Kiddie Schedule of Affective Disorders and Schizophrenia (WASH-U K-SADS) (Geller et al., 2000).
  • Patients must currently display symptoms of depression/dysthymia (Childhood Depression Rating Scale > 35) or mania/hypomania (Young Mania Rating Scale > 14).

Who cannot join

  • Patients will be excluded from the protocol for any of the following reasons:
  • Female patients who are either pregnant or lactating.
  • Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic, or other systemic medical conditions.
  • Neurologic disorders including epilepsy, stroke, or severe head trauma.
  • Clinically significant laboratory abnormalities on any of the following tests: complete blood count (CBC) with differential, electrolytes, BUN, creatinine, hepatic transaminases, thyroid stimulating hormone (TSH), and electrocardiogram (EKG).
  • Mood symptoms due to a general medical condition or substance-induced mania (DSM-IV).
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  • Mental retardation (intelligence quotient [IQ] < 70).
  • History of hypersensitivity to or intolerance to quetiapine.
  • Prior history of quetiapine non-response.
  • DSM-IV substance (except nicotine or caffeine) dependence within the past 3 months.
  • Judged clinically to be at serious suicidal risk.
  • Participation in a clinical trial of another investigational drug within 1 month (30 days) prior to study entry.
  • Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0.
  • Treatment with concurrent mood stabilizers or anticonvulsants, benzodiazepines (except as described below), psychostimulants, guanethidine, or guanadrel, or antidepressants.
  • 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, or psychotic disorder not otherwise specified) as defined in the DSM-IV.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

Other trials in United States

About this study

Official title: A Single-Blind Prospective Study of Quetiapine for the Treatment of Mood Disorders in Adolescents

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).

Read the 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.

Conditions
Mood Disorders
Being tested
quetiapine
Keywords
Adolescents
Medical subject headings
Mood Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • quetiapineDrug

    Also called Seroquel

    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).

Study groups in NCT00221468
Study groupRoleWhat they receive
QuetiapineExperimentalPatients will begin 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).
Receives: Drug: quetiapine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Global Impression Improvement (CGI)

    The Clinical Global Impression Improvement Score of < 2 (much or very much improved) will be used to quantify the adolescent's change in overall severity of illness.

    Measured: 12 weeks

Secondary outcomes (1)
  1. Young Mania Rating Scale (YMRS)

    The Young Mania Rating Scale (YMRS) will be used as a measure of efficacy (change in YMRS total scores from baseline to endpoint)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startJun 2003
  3. Primary completionApr 2006
  4. Study completionApr 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00221468
Sponsor's protocol ID
IRUSQUET0296
Status last verified
Mar 2007
First submitted
15 Sep 2005
Last updated
18 Jul 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing quetiapine in people with Mood Disorders, run by University of Cincinnati at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Global Impression Improvement (CGI) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2012.

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