Status:
COMPLETED
Efficacy of Quetiapine XR Versus Placebo as Concomitant Treatment to Mood Stabilizers in the Control of Subsyndromal Symptoms of Bipolar Disorder
Lead Sponsor:
Centro de Investigación Biomédica en Red de Salud Mental
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 tha...
Detailed Description
Remission of acute episodes usually doesn't correlate with symptomatic or functional recovery in occupational and social domains after (McQueen et al, 2001; Tohen et al, 2000) Ongoing depressive sympt...
Eligibility Criteria
Inclusion
- Informed Consent signature
- At least 18 years old
- Diagnoses of bipolar disorder I or II (as DSM-IV-TR 4ª Ed codes)
- 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)
- Presenting subsyndromal symptoms at enrolment and randomization point, defined as YMRS ≤ 14 and/ or MADRS ≥ 8 and ≤14
- At least one manic, mixed, or depressed episode in the last 5 years
- Being able to understand and meet the study requirements
Exclusion
- Pregnant or nursing women
- Mental retardation.
- 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
- Having suffered any acute episode (depressive, manic, or mixed) within the 8 weeks prior to enrolment, as defined in DSM-IV-TR
- Patients that, in the investigator's opinion, are at a high risk of suicide or mean a risk of aggression to others.
- Having been treated with any antidepressant at randomization.
- Having been treated with any mood stabilizer other than lithium/valproate/lamotrigine at randomization.
- 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)
- 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.
- 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.
- Any contraindication to the use of quetiapine fumarate in the investigator's opinion (including lack of response to it in previous treatment attempts)
- Suffering any medical condition that can effect the absorption, distribution, metabolism or excretion of the study treatment(s).
- Suffering any medical condition in decompensation or not receiving inappropriate treatment for it in the investigator's opinion (e.g., hyperthyroidism, angina pectoris, hypertension...)
- Suffering unstable diabetes at enrolment or randomization
- Absolute neutrophil count ≤ 1.5 x 109 per litre at randomization
- Non-compliance with the study plan.
- Participation in another clinical trial in the four weeks prior to randomization
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01197846
Start Date
September 1 2010
End Date
July 1 2012
Last Update
September 19 2012
Active Locations (10)
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1
Hospital Santa Creu I Sant Pau
Barcelona, Barcelona, Spain, 08025
2
Hospital Clinic I Provincial
Barcelona, Barcelona, Spain, 08036
3
Hosptial Benito Menni
Barcelona, Barcelona, Spain, 08830
4
Hospital Universitari de Bellvitge
Barcelona, Barcelona, Spain, 08907