Depressive episodes in bipolar disorder
Conditions
Interventions
Trade Name: Seroquel
Product Name: Seroquel IR Tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Quetiapine fumarate
CAS Number:
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent before initiation of any study related procedures. 2. Male and female patients aged 18 to 65 years, inclusive. 3. Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV, American Psychiatric Association 1994) criteria for bipolar I disorder or bipolar II disorder, most recent episode depressed (296.50-296.54 and 296.89 respectively) confirmed by the amended version of the Structured Clinical Interview for DSM-IV (SCID). 4. HAM-D (17-item) total score of =20 and HAM-D item 1 (depressed mood) score =2 at Visit 1 (Enrolment) and 2 (Randomisation). 5. Be able to understand and comply with the requirements of the study, as judged by the investigator. 6. Outpatient status at Visit1 (Enrolment) and Visit2 (Randomisation). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with a current DSM-IV Axis I disorder other than bipolar disorder that is symptomatic or requiring treatment within 6 months of enrolment. 2. YMRS total >12 at enrolment or randomisation. 3. Patients with more than 8 mood episodes during the past 12 months. 4. Patients whose current episode of depression exceeds 12 months or is less than 4 weeks from enrolment. 5. History of non-response to an adequate treatment (6 weeks) with more than 2 classes of antidepressants during their current episode. 6. Substance/alcohol dependence or abuse at enrolment (except dependence in full remission (>12 months) and except caffeine and nicotine dependence) as defined by DSM-IV criteria. Patients with a positive urine toxicology screen will be excluded only if they satisfy the DSM-IV criteria for abuse or dependence. However, a single urine toxicology screen for cocaine, heroin or PCP will lead to exclusion. 7. Use of drugs that induce or inhibit the hepatic metabolising cytochrome P450 3A4 enzymes within 2 weeks prior to randomisation or during the randomisation period (see Section 3.7.3, Table 5). 8. Use of the following medication: -antipsychotic, mood stabilizer, antidepressant, anxiolytic, hypnotic or other psychoactive drugs within 5 days before randomisation -fluoxetine within 28 days before randomisation -extended release risperidone within 14 days before randomisation -a depot antipsychotic injection within one dosing interval (for the depot) before randomisation -lithium within 7 days before randomisation and/or tapering off started less than 14 days before randomisation -irreversible monoamine oxidase inhibitors within 14 days before randomisation. 9. Patients who in the investigators opinion will require formalised psychotherapy during the study period, unless psychotherapy has been ongoing for a minimum of 3 months prior to randomisation. 10. Patients who, in the investigator’s judgment pose a current serious suicidal or homicidal risk, have a HAM-D item 3 score of 3 or greater, or have made a suicide attempt within the past 6 months. 11. Pregnancy or lactation. Female patients of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, ie, double-barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation, during the study. 12. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria: -Unstable DM defined as enrolment HbA1c (or HgA1c) >8.5%. -Admitted to hospital for treatment of DM or DM related illness in past 12 weeks. -Not under care of physician responsible for patient’s DM care. -Physician responsible for patient’s DM care has not indicated that patie
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate superior efficacy of quetiapine compared with placebo in the acute treatment of patients with bipolar depression by assessment of the change from randomisation to Week 8 in the MADRS total score.; Secondary Objective: 1. to demonstrate the efficacy of quetiapine in reducing suicidal ideation in acute treatment of patients with bipolar depression by assessment of change from randomisation to Week 8 in MADRS item 10, suicidal thought 2. to demonstrate the efficacy of quetiapine in reducing anxiety symptoms in acute treatment of patients with bipolar depression by assessment of change from randomisation to Week 8 in HAM-A total score (Hamilton 1959) 3. to demonstrate that quetiapine is superior to placebo in improving the level of functioning in acute treatment of patients with bipolar depression by assessment of change from randomisation to Week 8 in Sheehan Disability Scale (SDS) score (Sheehan 1983) and in the number of missed workdays and number of under-productive workdays ; Primary end point(s): the change from randomisation to Week 8 assessment in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score | — |
Countries
United Kingdom
Outcome results
None listed