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

NCT01197846 | Completed Phase 3

• 1 other identifier: D1443L00079
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 10

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 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

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• To assess the efficacy of quetiapine extended release (QTP XR) vs. placebo in the control of bipolar subsyndromal symptoms when added to previous mood stabilizer treatment (lithium/ valproate/lamotrigine)

  Study of 12 weeks follow-up

Secondary Outcomes (1)

• To assess the efficacy of QTP XR vs. placebo when added to previous mood stabilizer treatment (lithium/ valproate/lamotrigine) in functional level of bipolar patients with subsyndromal symptoms

  Study of 12 weeks follow-up

Study Arms (2)

Quetiapine

EXPERIMENTAL

Quetiapine 300 mg or 600 mg

Drug: Quetiapine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Quetiapine DRUG

quetiapine 300 mg or 600 mg

Also known as: Quetiapine XR

Quetiapine

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or nursing women
• Mental retardation.
• 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)
• 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

Sponsors & Collaborators

• Centro de Investigación Biomédica en Red de Salud Mental: lead

Study Sites (10)

Hospital Santa Creu I Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospital Clinic I Provincial

Barcelona, Barcelona, 08036, Spain

Location

Hosptial Benito Menni

Barcelona, Barcelona, 08830, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, Barcelona, 08907, Spain

Location

Parc Sanitari Sant Joan de Deu

Barcelona, Barcelona, 08940, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, 28009, Spain

Location

Hospital Universitario Ramon Y Cajal

Madrid, Madrid, 28034, Spain

Location

Centro de Salud Menta II

Oviedo, Oviedo, 33011, Spain

Location

Hosptial Clinico Valencia/ CSM Foios

Valencia, Valencia, 46134, Spain

Location

Hospital Santiago Apostol

Vitoria-Gasteiz, Vitoria, 01004, Spain

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Eduard Vieta, PhD

  Hospital Clinic I Provincial. Barcelona. Spain

  PRINCIPAL INVESTIGATOR

• Ana Gonzalez Pinto

  Hospital Santiago Apostol. Vitoria. Spain

  PRINCIPAL INVESTIGATOR

• Benedikt Amann

  Hospital Benito Menni. Barcelona. Spain

  PRINCIPAL INVESTIGATOR

• Celso Arango

  Hospital General Universitario Gregorio Marañon. Madrid. Spain

  PRINCIPAL INVESTIGATOR

• Jose Manuel Crespo

  Hospital Universitari de Bellvitge. Barcelona. Spain

  PRINCIPAL INVESTIGATOR

• Julio Bobes

  Centro de Salud Mental II. Oviedo. Spain

  PRINCIPAL INVESTIGATOR

• Josefina Perez

  Hospital Santa Creu I Sant Pau. Barcelona. Spain

  PRINCIPAL INVESTIGATOR

• Gabriel Selva

  Hospital Clinico de Valencia/ CSM Foios. Valencia. Spain

  PRINCIPAL INVESTIGATOR

• Belen Arranz

  Parc Sanitari Sant Joan de Deu. Barcelona. Spain

  PRINCIPAL INVESTIGATOR

• Jeronimo Saiz

  Hospital Universitario Ramon y Cajal. Madrid. Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD; PhD

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 9, 2010
• Study Start: September 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 19, 2012

Record last verified: 2012-09

Locations

ES (10)