Triiodothyronine as an adjunct in treatment of acute schizophrenia

Conditions: Acute Schizoprenia episode
MedDRA version: 9.1Level: LLTClassification code 10001065Term: Acute schizophrenia episode

Registration Number: EUCTR2007-001541-18-LT

Lead Sponsor: Institute of Psychophysiology and Rehabilitation (IRP) of the Kaunas University of Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1.Age =18 years of old and < 50 years of old.
2.Signed informed consent.
3.DSM-IV diagnosis of schizophrenia 295.1 – 295.9, at least half a year.
4.An acute psychotic episode at screening and at baseline (PANSS score 70-120, inclusive).
5.Good physical health based on a physical examination, ECG results and laboratory tests results at screening.

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

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.