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Efficacy of Quetiapine XR Versus Placebo as Concomitant Treatment to Mood Stabilizers in the Control of Subsyndromal Symptoms of Bipolar Disorder

NCT01197846 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2012-09-19

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Quetiapine

quetiapine 300 mg or 600 mg

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Centro de Investigación Biomédica en Red de Salud Mental

    lead NETWORK

Principal Investigators

  • Eduard Vieta, PhD · Hospital Clinic I Provincial. Barcelona. Spain

  • Ana Gonzalez Pinto · Hospital Santiago Apostol. Vitoria. Spain

  • Benedikt Amann · Hospital Benito Menni. Barcelona. Spain

  • Celso Arango · Hospital General Universitario Gregorio Marañon. Madrid. Spain

  • Jose Manuel Crespo · Hospital Universitari de Bellvitge. Barcelona. Spain

  • Julio Bobes · Centro de Salud Mental II. Oviedo. Spain

  • Josefina Perez · Hospital Santa Creu I Sant Pau. Barcelona. Spain

  • Gabriel Selva · Hospital Clinico de Valencia/ CSM Foios. Valencia. Spain

  • Belen Arranz · Parc Sanitari Sant Joan de Deu. Barcelona. Spain

  • Jeronimo Saiz · Hospital Universitario Ramon y Cajal. Madrid. Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-02-29
Completion
2012-07-31

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01197846 on ClinicalTrials.gov