The Efficacy of Thiothixine In Bipolar Disorder
Phase 2
- Conditions
- Bipolar disorder, Manic phase, Psychotic.Bipolar Affective disorder, Current Episode Manic With Psychotic Symptoms
- Registration Number
- IRCT201110203770N2
- Lead Sponsor
- euroscience Research Center, Kerman University Of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 84
Inclusion Criteria
1- 18-60 year’s old patients; 2- Psychotic mania according to DSM-IV-IR; 3- Score > 20 in Young Mania Rating Scale. Exclusion criteria: 1- Medical conditions as diabetes mellitus and epilepsy; 2- Evidence of mental retardation as IQ < 70; 3- Receiving any psychotropic medication, opioid and stimulants through four weeks before entering trial.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Symptoms severity of mania. Timepoint: Baseline, week 2, 4, 6 and 8 weeks after the drugs started. Method of measurement: Young Mania Rating Scale.
- Secondary Outcome Measures
Name Time Method Weight. Timepoint: baseline and the end of week 8. Method of measurement: weighing the patient.;Fasting blood suger. Timepoint: baseline and the end of week 8. Method of measurement: lab.;Anxiety severity. Timepoint: Baseline, week 2, 4, 6, 8. Method of measurement: Hamilton Rating Scale for Anxiety.;Deression severity. Timepoint: Baseline, week 2, 4, 6, 8. Method of measurement: Hamilton Rating Scale for Deression.;Psychosis severity. Timepoint: Baseline, week 2, 4, 6, 8. Method of measurement: Positive and Negative Syndrome Scale.;Side effects. Timepoint: Week 2, 4, 6, 8. Method of measurement: Check list.