Depressive episode MedDRA version: 9.1 Level: LLT Classification code 10012402 Term: Depressive episode
Conditions
Interventions
Trade Name: Thybon 20 Henning
Thybon 100 Henning
Product Name: THYBON
Pharmaceutical Form: Tablet
INN or Proposed INN: LIOTHYRONINE HYDROCHLORIDE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number:
Sponsors
Institute of Psychophysiology and Rehabilitation (IRP) of the Kaunas University of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Inclusion criteria: (1) Women, 18-60 years, (2) DSM-IV/ICD-10 diagnosis of single or recurrent non-psychotic major depressive disorder (MDD) 296.2–296.3/F32.1-F32-2. (3) Score of 20 or more on 17-item Ham-D scale. (4) Good physical health based on a physical examination, ECG and laboratory tests. (5) Signed Informed Consent. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (1) Current DSM-IV/ICD-10 diagnosis of psychoses or dementia, as well as, mania, OCD, organic disorder, personality disorder. (2) DSM-IV/ICD-10 diagnosis of substance dependence within six month prior to screening. (3) Score of suicidality more than ten on the MINI. (4) Thyroid disease (including subclinical euthyroid autoimmune thyroid disease) or use of a thyroid hormone, antithyroid medication and amiodarone. (5) Known allergic reactions to SSRI or T3, history of serotoninergic syndrome. (6) ECT within three month before screening. (7) Pregnancy or breastfeeding. (8) Patients treated with fluexetine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effects of 10 mg of ESC with 25 µg of T3 (T325) versus 10 mg of ESC with placebo (P) on depression. The 17-item Hamilton Rating Scale for Depression (Ham-D) will be used as primary outcome measure. ;Secondary Objective: To evaluate the safety of ESC +T325 in comparison to ESC +P. To evaluate effects of T3 vs. P on basal metabolic rate and on autonomic function in patients treated for depression with ESC.;Primary end point(s): The reduction in total score on Ham-D on Day 4 and Day 7 will be significantly greater in patients receiving ESC +T325 in comparison to patients receiving ESC + P (ESC +T325 will act faster). | — |
Countries
Lithuania
Outcome results
None listed