An International, Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase III study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel™, single oral 300 mg or 600 mg dose) and Paroxetine as Monotherapy in Adult Patients with Bipolar Depression for 8 weeks and Quetiapine in Continuation Treatment for 26 up to 52 weeks. - N/A
- Conditions
- Depressive episodes in bipolar disorder
- Registration Number
- EUCTR2004-004909-16-GB
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 660
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method