The Efficacy of Thiothixine In Bipolar Disorder

The comparison of efficacy and side effects of combined Thiothixine-Lithium and Risperidone-Lithium treatment in psychotic bipolar patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201110203770N2

Enrollment

Registered

2012-01-18

Start date

2011-11-21

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar disorder, Manic phase, Psychotic. Bipolar Affective disorder, Current Episode Manic With Psychotic Symptoms

Interventions

Intervention 1: Intervention 1: Lithium at dose producing serum concentration of .8 - 1.2 meq /lit + thiothixine with starting dose of 5 mg and target dose of 15 mg/day. Intervention 2: Intervention 2

Treatment - Drugs

Intervention 1: Lithium at dose producing serum concentration of .8 - 1.2 meq /lit + thiothixine with starting dose of 5 mg and target dose of 15 mg/day.

Intervention 2: Lithium at dose producing serum level of .8 - 1.2 meq/lit + risperidone with starting dose of 2 mg and target dose of 6 mg/day.

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNooshin Parvaresh

Kerman University of Medical Sciences

n_parvaresh@kmu.ac.ir, n_parvaresh@yahoo.com+98 34 1211 6328

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026