Mood Disorders Clinical Trial
Official title:
A Single-Blind Prospective Study of Quetiapine for the Treatment of Mood Disorders in Adolescents
Verified date | March 2007 |
Source | University of Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 20 |
Est. completion date | April 2006 |
Est. primary completion date | April 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years to 18 Years |
Eligibility |
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 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). 5. Patients must currently display symptoms of depression/dysthymia (Childhood Depression Rating Scale > 35) or mania/hypomania (Young Mania Rating Scale > 14). 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. Neurologic disorders including epilepsy, stroke, or severe head trauma. 4. 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). 5. Mood symptoms due to a general medical condition or substance-induced mania (DSM-IV). 6. Mental retardation (intelligence quotient [IQ] < 70). 7. History of hypersensitivity to or intolerance to quetiapine. 8. Prior history of quetiapine non-response. 9. DSM-IV substance (except nicotine or caffeine) dependence within the past 3 months. 10. Judged clinically to be at serious suicidal risk. 11. Participation in a clinical trial of another investigational drug within 1 month (30 days) prior to study entry. 12. Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0. 13. Treatment with concurrent mood stabilizers or anticonvulsants, benzodiazepines (except as described below), psychostimulants, guanethidine, or guanadrel, or antidepressants. 14. 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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
University of Cincinnati | AstraZeneca |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 12 weeks | No |
Secondary | 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) | 12 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Recruiting |
NCT05345392 -
Brain, Emotions, and Mind-Wandering
|
N/A | |
Completed |
NCT05078450 -
Mood Lifters Online for Graduate Students and Young Professionals
|
N/A | |
Not yet recruiting |
NCT04551027 -
Assessing the Effect of Compensatory Cognitive Intervention Among People With Severe Mental Illness
|
N/A | |
Recruiting |
NCT03088657 -
Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study
|
||
Active, not recruiting |
NCT02542475 -
Low Field Magnetic Stimulation: Open Label Study.
|
Phase 1/Phase 2 | |
Completed |
NCT00916552 -
Effects of Erythropoietin on Depressive Symptoms and Neurocognitive Deficits in Depression and Bipolar Disorder
|
Phase 2 | |
Completed |
NCT00202514 -
Placebo Controlled Trial of Depakote ER in Alcohol Dependent Patients With Mood and/or Anxiety Symptoms
|
Phase 2/Phase 3 | |
Completed |
NCT00217932 -
Effectiveness of Divalproex Sodium (Depakote) in Treating Children With Temper Outbursts and Severe Mood Swings
|
Phase 2 | |
Completed |
NCT00006517 -
Clinical Trials of Three Non-Drug Treatments for Winter Depression (SAD)
|
N/A | |
Terminated |
NCT03898843 -
Assisted Animal Therapy: ReAnimal
|
N/A | |
Active, not recruiting |
NCT04358900 -
Unobtrusive Monitoring of Affective Symptoms and Cognition Using Keyboard Dynamics (UnMASCK)
|
||
Recruiting |
NCT06360562 -
Reconnecting to Ourselves and Others in Virtual Meetings (ROOM)
|
N/A | |
Completed |
NCT05745103 -
Optimizing Behavioral Healthcare Delivery Through Technology
|
N/A | |
Suspended |
NCT03715400 -
Mobile Virtual Positive Experiences for Anhedonia
|
N/A | |
Enrolling by invitation |
NCT03736538 -
Nitrous Oxide- Suicidal Ideation
|
Phase 1 | |
Completed |
NCT04601545 -
The Virtual Reality Therapy as a Pulmonary Rehabilitation Supporting Method
|
N/A | |
Completed |
NCT02566980 -
Biological Triggers of Depression in Pregnancy
|
||
Completed |
NCT03743844 -
Psychosocial Intervention for Women With Mood Disorders Seeking Treatment for Obesity
|
N/A | |
Completed |
NCT05211063 -
Effects of CROCUVIS+® on Computer Vision Syndrome, Sleep and Mood Disorders
|
N/A |