Objective: The efficacy and side effects of combined thiothixine- lithium in treatment of patients with psychotic mania will be compared with risperidone - lithium. Method: A total of 84 hospitalized patients with diagnosis of psychotic mania as defined by DSM-IV- IR receive lithium ( 300 mg/TID, dose increase to achieve serum level of .8-1.2 meq/lit ) and randomize to receive thiothxine (5 - 15 mg/day) or risperidone (2- 6 mg/day) for a 8-week. The dose will be adjusted according to intolerable side effects. The principle measure of outcome is Young Mania Rating Scale. Side effects will be checked by checklist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110203770N2
Registration date:2012-01-18, 1390/10/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-01-18, 1390/10/28
Registrant information
Name
Nooshin Parvaresh
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 6328
Email address
n_parvaresh@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Neuroscience Research Center, Kerman University of Medical Sciences
Expected recruitment start date
2011-11-21, 1390/08/30
Expected recruitment end date
2012-11-20, 1391/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of efficacy and side effects of combined Thiothixine-Lithium and Risperidone-Lithium treatment in psychotic bipolar patients
Public title
The Efficacy of Thiothixine In Bipolar Disorder
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Neuroscience Research Center, Kerman University Of Medical Sciences
Street address
Neuroscience Research Center, Ebn-e-sina avenue, Jahad blvd
City
Kermen
Postal code
Approval date
2011-11-21, 1390/08/30
Ethics committee reference number
cc/knrc/90-17
Health conditions studied
1
Description of health condition studied
Bipolar disorder, Manic phase, Psychotic
ICD-10 code
F31.2
ICD-10 code description
Bipolar Affective disorder, Current Episode Manic With Psychotic Symptoms
Primary outcomes
1
Description
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 outcomes
1
Description
Anxiety severity
Timepoint
Baseline, week 2, 4, 6, 8.
Method of measurement
Hamilton Rating Scale for Anxiety
2
Description
Deression severity
Timepoint
Baseline, week 2, 4, 6, 8
Method of measurement
Hamilton Rating Scale for Deression
3
Description
Psychosis severity
Timepoint
Baseline, week 2, 4, 6, 8
Method of measurement
Positive and Negative Syndrome Scale
4
Description
Side effects
Timepoint
Week 2, 4, 6, 8
Method of measurement
Check list
5
Description
weight
Timepoint
baseline and the end of week 8
Method of measurement
weighing the patient
6
Description
fasting blood suger
Timepoint
baseline and the end of week 8
Method of measurement
lab
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Nooshin Parvaresh
Street address
Shahid Beheshti Hospital, Jomhouri Islami blvd
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Neuroscience Research Center, Kerman University Of Medical Sciences
Full name of responsible person
Dr.Vahid Sheibani
Street address
Neuroscience Research Center, Ebn-e-sina avenue, Jahad blvd
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neuroscience Research Center, Kerman University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Nooshin Parvaresh
Position
MD, assisstant professor
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Jomhouri Islami blvd
City
Kerman
Postal code
Phone
+98 34 1211 6328
Fax
Email
n_parvaresh@kmu.ac.ir, n_parvaresh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Nooshin Parvaresh
Position
MD, assisstant professor
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Jomhouri Islami blvd
City
Kerman
Postal code
Phone
+98 34 1211 6328
Fax
+98 34 1211 0856
Email
n_parvaresh@kmu.ac.ir, n_parvaresh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Nooshin Parvaresh
Position
MD, assisstant professor
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Jumhouri Islami blvd
City
Kerman
Postal code
7618834115
Phone
+98 34 1211 6328
Fax
+98 34 1211 0856
Email
n_parvaresh@kmu.ac.ir, n_parvaresh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)