Acute Schizoprenia episode MedDRA version: 9.1 Level: LLT Classification code 10001065 Term: Acute schizophrenia episode
Conditions
Interventions
Trade Name: Thybon 20 Henning
Thybon 100 Henning
Product Name: THYBON
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LIOTHYRONINE HYDROCHLORIDE
Concentration unit: µg microgram(s)
Concen
Sponsors
Institute of Psychophysiology and Rehabilitation (IRP) of the Kaunas University of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age =18 years of old and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Current DSM-IV axis I diagnosis other than schizophrenia. 2.DSM-IV diagnosis of substance dependence within six month prior to screening. 3.Any medical condition that potentially can alter absorption, metabolism or excretion of the medication (Crohn's disease, liver disease, renal disease). 4.Injection of depot antipsychotics within 120 days before screening. 5.History or presence of any significant or unstable cardiovascular, respiratory, neurological, seizures, cerebrovascular, renal, hepatic, endocrine or immunologic disease, unstable systemic diseases. 6.Thyroid disorder or use of a thyroid medication. 7.Significant risk of suicidal or violent behavior. 8.Known allergic reactions to risperidone or T3, history of neuroleptic malignant syndrome and tardive dyskinesia. 9.Use of MAO inhibitors within four weeks before screening 10.ECT within three month before screening. 11.Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effects of risperidone (RIS) in combination with triiodothyronine (T3) versus RIS in combination with placebo (P) on positive and negative symptoms of patients hospitalized for acute schizophrenia. The dose of RIS shall be flexible; the dose of T3 shall be fixed at 25 ug per day (T325). ;Secondary Objective: In patients with acute schizophrenia to compare the effects of RIS+ T325 versus RIS+P on symptoms of depression measured by the Hamilton Depression Rating (Ham-D) scale, on symptoms of anxiety measured by the Hamilton Anxiety Rating (Ham-A) scale, on symptoms of mania measured by the Young mania rating scale (YMRS), and on the clinical global impression scales for severity (CGI-S) and for improvement (SGI-I). To compare side effects of RIS+T325 versus side effects of RIS+P measured by the Barnes akathisia rating scale, by the Simpson scale for extra-pyramidal side effects and by assessment of heart rate and blood pressure.;Primary end point(s): The reduction in total score on Positive and Negative Syndrome Scale (PANSS) six weeks after treatment will be greater in patients receiving RIS+T325 in comparison to patients receiving RIS+P. | — |
Countries
Lithuania
Outcome results
None listed