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Conditions: Bipolar disorder
MedDRA version: 18.0Level: HLTClassification code 10004938Term: Bipolar disordersSystem Organ Class: 100000004873
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2014-003803-31-ES

Lead Sponsor: Hospital Universitario Araba (Sede Santiago)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: - 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.<br>- Evaluate whether the pro / anti-inflammatory status correlates with response to pioglitazone tratamientl of TB<br>- compare cognitive functioning in patients with pioglitazone versus placebo patients<br>- Evaluate the effectiveness of pioglitazone in the treatment of cognitive deficits detected in patients with TB<br>- Evaluate the influence of pioglitazone treatment in BDNF levels in patients with TB.;Primary end point(s): The primary dependent variable is the change in the clinical condition measured by the CGI-BP-M (Vieta 2002) scale patient.;Timepoint(s) of evaluation of this end point: No

Secondary Outcome Measures