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    Summary
    EudraCT Number:2014-003803-31
    Sponsor's Protocol Code Number:PIO-BP
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-10-20
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-003803-31
    A.3Full title of the trial
    Adjunct pioglitazone IN THE TREATMENT OF BIPOLAR DISORDER.
    PIOGLITAZONA COMO COADYUVANTE EN EL TRATAMIENTO DEL TRASTORNO BIPOLAR.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    No
    A.3.2Name or abbreviated title of the trial where available
    PIO-BP
    A.4.1Sponsor's protocol code numberPIO-BP
    A.5.4Other Identifiers
    Name:NoNumber:No
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHospital Universitario Araba (Sede Santiago)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNo
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario Araba (Sede Santiago)
    B.5.2Functional name of contact pointAna Gonzalez-Pinto
    B.5.3 Address:
    B.5.3.1Street AddressC/ Olaguibel, 29
    B.5.3.2Town/ cityVitoria-Gasteiz
    B.5.3.3Post code01004
    B.5.3.4CountrySpain
    B.5.4Telephone number+34945007764
    B.5.6E-mailmonica.martinezcengotitabengoa@osakidetza.net
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePioglitazona
    D.3.2Product code A10BG03
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPIOGLITAZONE
    D.3.9.1CAS number 111025-46-8
    D.3.9.4EV Substance CodeSUB09857MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number15 to 45
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bipolar disorder
    Trastorno bipolar
    E.1.1.1Medical condition in easily understood language
    Bipolar disorder
    Trastorno bipolar
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLT
    E.1.2Classification code 10004938
    E.1.2Term Bipolar disorders
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the study is to determine the efficacy and safety of pioglitazone as an adjunct to standard therapy in the treatment of patients with TB therapy.
    El objetivo principal del estudio es determinar la eficacia y seguridad de pioglitazona como terapia coadyuvante a la terapia estándar en el tratamiento de pacientes con TB.
    E.2.2Secondary objectives of the trial
    - To determine the proportion of patients in the intervention group who manage to achieve remission of the episode after treatment compared with the control group.
    - Evaluate whether the pro / anti-inflammatory status correlates with response to pioglitazone tratamientl of TB
    - compare cognitive functioning in patients with pioglitazone versus placebo patients
    - Evaluate the effectiveness of pioglitazone in the treatment of cognitive deficits detected in patients with TB
    - Evaluate the influence of pioglitazone treatment in BDNF levels in patients with TB.
    - Determinar la proporción de pacientes en el grupo de intervención que logran alcanzar la remisión del episodio tras el tratamiento en comparación con el grupo control.
    - Evaluar si el estatus pro/antiinflamatorio correlaciona con la respuesta a pioglitazona en el tratamientl del TB
    - Comparar el funcionamiento cognitivo en pacientes con pioglitazona versus pacientes con placebo
    - Evaluar la eficacia de pioglitazona en el tratamiento de los déficits cognitivos detectados en pacientes con TB
    - Evaluar la influencia del tratamiento con pioglitazona en los niveles de BDNF en pacientes con TB.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - In the opinion of the participant researcher is able to understand and comply with the requirements of the protocol.
    - Age between 18-45 years
    - The patient meets DSM-IV diagnostic criteria for BD I or II
    - Currently the patient is suffering from a manic, depressive, or mixed episode with a score on the CGI-BP-M greater than or equal to 4 scale
    - The patient is under treatment with a mood stabilizer (lithium, valproate or lamotrigine) monotherapy at a stable dose for 30 days prior to inclusion in the study.
    - Spanish is fluent
    - Signature of prior informed consent to any study procedures.
    - Women of Reproductive Age UN must obtain m negative pregnancy test in serum or urine screening visit and accept the use of adequate contraception.
    - En opinión de investigador el participante es capaz de entender y cumplir con los requerimientos del protocolo.
    - Edad entre 18-45 años
    - El paciente cumple criterios diagnósticos DSM-IV de TB I o II
    - Actualmente el paciente se encuentra sufriendo un episodio maníaco, depresivo o mixto con una puntuación en la escala CGI-BP-M mayor o igual a 4
    - El paciente se encuentra bajo tratamiento con un estabilizador del ánimo (litio, valproato o lamotrigina) en monoterapia, en una dosis estable desde 30 días antes a la inclusión en el estudio.
    - Habla español correctamente
    - Firma del consentimiento informado previamente a cualquier procedimiento del estudio.
    E.4Principal exclusion criteria
    - History of head trauma with loss of consciousness or somatic pathology impact on the mental level that could affect the patient's ability to participate in the study.
    - Women of childbearing potential not ensure the use of contraceptive methods.
    - Women breastfeeding
    - The participant has received pioglitazone or another thiazolidinedione in a previous clinical study or as a therapeutic agent in the year prior to the study screening
    - History of hypersensitivity or allergy to any component of the formulation piioglitazona, compounds related to her or placebo components
    - Patients of osteoporosis
    - Presence of diabetes mellitus by the patient must be treated with insulin or other PPARy agonists.
    - Current or history of heart failure, personal or family history of bladder cancer or diabetic ketoacidosis
    - Background of macular edema, macular degeneration or any maculopathy.
    - Acute inflammatory disease
    - Have taken an anti-inflammatory agent, antibiotic or some type of vaccine in the 7 days prior to the time of enrollment in the study.
    - Historia de traumatismo craneoencefálico con pérdida de consciencia o patología somática con impacto a nivel mental que pudiera afectar a la capacidad del paciente de participar en el estudio.
    - Mujeres en edad fértil que no aseguren el uso de métodos contraceptivos.
    - Mujeres en periodo de lactancia
    - El participante ha recibido pioglitazona u otra tiazolidindiona en un estudio clínico previo o como agente terapéutico en el año previo a la selección para el estudio
    - Historia de hipersensibilidad o alergia a algún componente de la formulación de pioglitazona, compuestos relacionados con ella o a los componentes del placebo
    - Presencia de diabetes mellitus por la que el paciente deba ser tratado con insulina u otros agonistas PPAR.
    - Actual o historia de fallo cardiaco, historia personal o familiar de cáncer de vejiga o de cetoacidosis diabética
    - Antecedentes de edema macular, degeneración macular o de cualquier maculopatía.
    - Enfermedad inflamatoria aguda
    - Haber tomado un agente antiinflamatorio, antibiótico o algún tipo de vacuna en los 7 días previos a la visita de inclusión en el estudio.
    - Pacientes con osteoporosis
    E.5 End points
    E.5.1Primary end point(s)
    The primary dependent variable is the change in the clinical condition measured by the CGI-BP-M (Vieta 2002) scale patient.
    La principal variable dependiente será el cambio en la condición clínica del paciente medido a través de la escala CGI-BP-M (Vieta 2002).
    E.5.1.1Timepoint(s) of evaluation of this end point
    No
    E.5.2Secondary end point(s)
    - Hamilton Depression Scale.
    - Young Mania Rating Scale.
    - Collect one Sociodemographic Through Questionnaire Designed former UN process.
    - Personal psychiatric BACKGROUND.
    - Personal Health Record.
    - Physical Examination (weight, height, BMI, abdominal circumference).
    - General analysis (blood count, glucose, glycosylated hemoglobin, total cholesterol, HDL, LDL, triglycerides, prolactin, thyroid hormones, electrolytes.).
    - Consumption of Toxic (Urinalysis).
    - Cardiovascular risk (Framingham index, metabolic syndrome, HOMA index) at the beginning and Treatment fin.
    - Evaluation of Adverse Events to medication one Through the UKU scale. (Lingjaerde, Ahlfors et al., 1987). Also collect all those adverse events reported by patients FURTHER those Collected in the UKU scale.
    - Neuropsychological Evaluation: basing on the Review of the literature (Lezak, 2004; Spreen and Strauss 1998), yes Pasaran The Following Instruments, among those who are the most frequently used in cognitive assessment of patients with TB (Goodwin and Jamison 2007; Martinez-Aran et al, 2000):
    1. premorbid intellectual Ratio Estimate: Vocabulary subtest (WAIS-III; Wechsler, 1997).
    2. SPEED Processing (WAIS-III, Wechsler 1997) Symbol key numbers.
    3. Executive Functions Front:
    - Wisconsin Card Sorting Test
    - Test Stroop word-color interference (SCWT) (Golden et al 1995) and FAS (Controlled Oral Word Association Test) (Benton and Hamser 1978).
    4. Attention and Working Memory:
    - Trail Making (TMT) (Reitan and Wolfson, 1985).
    - Continous Performance Test (CPT-II) (Conners 2000).
    5. Working Memory (WAIS-III; Wechsler, 1997)
    - Arithmetic.
    - Digits.
    - Letters and Numbers.
    6. Verbal Memory:
    - California Lerning Verbal Test (Delis, Kramer, Kaplan and Ober 1987)
    - Logic Memory (WMS-III, Wechsler 2004)
    - Visual Memory: Rey-Osterreith Figure Test (Osterreith 1944; Rey 1941b)
    7. Social cognition: the scale GEOPTE
    - Biological Determinations
    - Escala de Depresión de Hamilton.
    - Escala de Manía de Young.
    - Datos sociodemográficos Recogidos un Través de la ONU Cuestionario Diseñado ex Proceso.
    - ANTECEDENTES Personales psiquiátricos.
    - Historia personal de Salud.
    - Examen Físico (peso, talla, IMC, Perímetro abdominal).
    - Análisis general (hemograma, glucosa, hemoglobina glicosilada, colesterol total. HDL, LDL, triglicéridos, prolactina, Hormonas tiroideas, Electrolitos).
    - Consumo de Tóxicos (Análisis de Orina).
    - Riesgo Cardiovascular (indice de Framingham, síndrome metabólico, HOMA Índice) al inicio y al aleta del Tratamiento.
    - Evaluation de los Eventos adversos a la medicación un Través de la escala UKU. (Lingjaerde, Ahlfors et al., 1987). Recogeremos Also Todos aquellos Eventos adversos relatados Por los Pacientes ADEMÁS de aquellos Recogidos en la escala UKU.
    - Evaluation neuropsicológica: basandonos en la Revisión de la literatura al respecto (Lezak 2004; Spreen y Strauss 1998), sí Pasaran Los Siguientes Instrumentos, Entre Los Que sí encuentran los mas frecuentemente utilizados en la VALORACIÓN cognitiva de Pacientes Con TB (Goodwin y Jamison 2007; Martínez-Arán y col, 2000):
    1. Cociente intelectual premórbido Estimado: subtest Vocabulario (WAIS-III; Weschler 1997).
    2. VELOCIDAD de Procesamiento (WAIS-III, Weschler 1997) Simbolos y clave de Números.
    3. Funciones Ejecutivas Frontales:
    - Wisconsin Card Sorting Test
    - Prueba de interferencia Stroop Palabra-Color (SCWT) (Golden y col 1995) y FAS (Controlado prueba Oral Word Association) (Benton y Hamser 1978).
    4. Atención y memoria de Trabajo:
    - Trail Making (TMT) (Reitan y Wolfson, 1985).
    - Continous Performance Test (CPT-II) (Conners 2000).
    5. Memoria de Trabajo (WAIS-III; Weschler 1997)
    - Aritmética.
    - Digitos.
    - Letras y Números.
    6. Memoria verbal:
    - California Lerning Verbal Test (Delis, Kramer, Kaplan y Ober 1987)
    - Memoria logica (WMS-III, Weschler 2004)
    - Memoria visual: Rey-Osterreith Figura Test (Osterreith 1944; Rey 1941b)
    7. cognición social: la escala GEOPTE
    - Determinaciones Biológicas
    E.5.2.1Timepoint(s) of evaluation of this end point
    No
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    No
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days90
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-20
    P. End of Trial
    P.End of Trial StatusOngoing
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