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.
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
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 group | Role | What they receive |
|---|---|---|
| Quetiapine | Experimental | Patients 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.
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)
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.
- First posted22 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Melissa Delbello, University of Cincinnati
- Investigators
- Melissa P DelBello, MD, Principal investigator, University of Cincinnati
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind Prospective Study of Quetiapine for the Treatment of Mood Disorders in Adolescents
- ClinicalTrials.gov ID
- NCT00221468
- Acronym / sponsor ID
- IRUSQUET0296
- Conditions
- Mood Disorders
- Keywords
- Adolescents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jun 2003
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quetiapine | Experimental | Drug: quetiapinePatients 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). |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quetiapineAlso: Seroquel100mg 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). | Drug | Quetiapine |
Primary outcome
Clinical Global Impression Improvement (CGI)
Time frame: 12 weeks
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.
1 secondary outcome
Young Mania Rating Scale (YMRS)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa P DelBello, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
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.