Bipolar disorder MedDRA version: 18.0 Level: HLT Classification code 10004938 Term: Bipolar disorders System Organ Class: 100000004873
Conditions
Interventions
Product Name: Pioglitazona
Product Code: A10BG03
Pharmaceutical Form: Tablet
INN or Proposed INN: PIOGLITAZONE
CAS Number: 111025-46-8
Concentration unit: mg milligram(s)
Concentration type: range
Con
Sponsors
Hospital Universitario Araba (Sede Santiago)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. - 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.;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
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: No;Secondary 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) - Lo | — |
Countries
Spain
Contacts
Public ContactAna Gonzalez-Pinto
Hospital Universitario Araba (Sede Santiago)
Outcome results
None listed