Overview
Efficacy of Quetiapine XR Versus Placebo as Concomitant Treatment to Mood Stabilizers in the Control of Subsyndromal Symptoms of Bipolar Disorder
Status:
Completed
Completed
Trial end date:
2012-07-01
2012-07-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Pilot multicentric, prospective, placebo controlled, randomized double blinded, study of 12 weeks follow-up Adult patients diagnosed of bipolar disorder I or II, in previous treatment with no more than two concomitant mood stabilizers at stable doses and current subsyndromal symptoms, defined as YMRS ≤14 and/ or MADRS≥8 and ≤14 would be included Sub-acute phases would be excluded (at least 8 weeks from last exacerbation would be required for inclusion).Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Centro de Investigación Biomédica en Red de Salud MentalTreatments:
Quetiapine Fumarate
Criteria
Inclusion Criteria:1. Informed Consent signature
2. At least 18 years old
3. Diagnoses of bipolar disorder I or II (as DSM-IV-TR 4ª Ed codes)
4. Previous treatment with a mood stabilizer (lithium, valproate or lamotrigine) at
stable and optimum doses for at least six weeks prior to the start of the trial (i.e.,
on the same dose and serum levels within the therapeutic ranges: 0.6-1.2 mEq/l of
lithium or 50-100 ug/ml of valproate)
5. Presenting subsyndromal symptoms at enrolment and randomization point, defined as YMRS
≤ 14 and/ or MADRS ≥ 8 and ≤14
6. At least one manic, mixed, or depressed episode in the last 5 years
7. Being able to understand and meet the study requirements
Exclusion Criteria:
1. Pregnant or nursing women
2. Mental retardation.
3. Current active diagnoses of any axis I or II DSM-IV-TR diagnoses different from
bipolar disorder I or II. This doesn't apply to nicotine nor caffeine
abuse-dependence. Punctual alcohol and/or substances use not constitutive of a
diagnoses of abuse or dependence following DSM-IV-TR criteria wouldn't suppose the
exclusion of the patient from the study. Anxiety in levels not constitutive of any
anxiety disorder within those codified in DSM-IV-TR wouldn't either suppose the
exclusion of the patient from the study
4. Having suffered any acute episode (depressive, manic, or mixed) within the 8 weeks
prior to enrolment, as defined in DSM-IV-TR
5. Patients that, in the investigator's opinion, are at a high risk of suicide or mean a
risk of aggression to others.
6. Having been treated with any antidepressant at randomization.
7. Having been treated with any mood stabilizer other than lithium/valproate/lamotrigine
at randomization.
8. Having been treated with any oral antipsychotic drug at randomization. Administration
of a depot antipsychotic medication within one dosing interval prior to randomization
(e.g. Long acting Risperidone 2 weeks; Zuclopenthixol 4 weeks; Pipotiazine 4 weeks;
Flufenazine 6 weeks)
9. Having been treated with any of the following P450-3A4 cytochrome inhibitors in the 14
days prior to inclusion, including: ketoconazole, itraconazole, fluconazole,
erythromycin, clarithromycin, fluvoxamine, indinavir, nelfinavir, ritonavir and
saquinavir.
10. Having been treated with any of the following P450-3A4 cytochrome inducers in the 14
days prior to inclusion, including: phenytoin, carbamazepine, barbiturates,
rifampicin, St. John's wart, and glucocorticoids.
11. Any contraindication to the use of quetiapine fumarate in the investigator's opinion
(including lack of response to it in previous treatment attempts)
12. Suffering any medical condition that can effect the absorption, distribution,
metabolism or excretion of the study treatment(s).
13. Suffering any medical condition in decompensation or not receiving inappropriate
treatment for it in the investigator's opinion (e.g., hyperthyroidism, angina
pectoris, hypertension...)
14. Suffering unstable diabetes at enrolment or randomization
15. Absolute neutrophil count ≤ 1.5 x 109 per litre at randomization
16. Non-compliance with the study plan.
17. Participation in another clinical trial in the four weeks prior to randomization