The aim of the study is comparing haloperidol with risperidone in the treatment of positive symptoms of psychosis among methamphetamine dependent patients (Phase II clinical trials). The population of this non blinded study is the inpatients of Razi psychiatric hospital in Tehran who met DSM.IV-TR criteria for methamphetamine-associated psychosis (MAP). 44 patients, who had the inclusion criteria, were randomly selected. Inclusion criteria: Patient between 18 to 60 Years; signing informed consent. Exclusion criteria: presence of other psychiatric disorders; abusing of other psycho stimulant drugs; comorbidity of neurological disorders; mental retardation. The subjects were randomly (simple random sampling using random number table) assigned to treatment groups (rispridone or haloperidol). Group 1, 22 patients received Haloperidol (5 to 20 mg, per day) and group 2, 22 patients received Risperidone (2 to 8 mg, per day) for 3 consecutive weeks. Patients were followed one week after interventions. The primary outcome was positive symptoms of psychosis. The Scale for the Assessment of Positive Symptoms (SAPS) was weekly completed for each patient.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201507155280N19
Registration date:2016-01-15, 1394/10/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-15, 1394/10/25
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of research, University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2012-08-31, 1391/06/10
Expected recruitment end date
2013-02-28, 1391/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Metamphetamine associated psychosis treatment with haloperidol versus rispridone: a clinical trial
Public title
Methamphetamine associated psychosis and treatment with risperidone and halopridol
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patient in the age range 18 to 60; signing informed consent. Exclusion criteria: presence of other psychiatric disorders; abusing of other psycho stimulant drugs; comorbid neurological disorders; mental retardation.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Simple random sampling using random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of University of Social Welfare and Rehabilitation Sciences
Street address
Zip code: 1985713834, University of Social Welfare and Rehabilitation Sciences, Koodakyar Street, Daneshjoo Blv, Evin, Tehran, Iran, Islamic Republic Of
City
Tehran
Postal code
Approval date
2012-09-23, 1391/07/02
Ethics committee reference number
REC.1392.111
Health conditions studied
1
Description of health condition studied
Methamphetamine-associated psychosis
ICD-10 code
F15
ICD-10 code description
Mental and behavioural disorders due to use of other stimulants, including caffeine
Primary outcomes
1
Description
Methamphetamine-associated psychosis
Timepoint
Baseline, the first week after intervention, the second week after intervention, the third week after intervention, the first week after finishing the intervention
Method of measurement
Scale of Assessment of Positive Symptoms (SAPS)
Secondary outcomes
empty
Intervention groups
1
Description
Group 1 received Haloperidol (5 to 20 mg, per day) for 3 weeks.
Category
Treatment - Drugs
2
Description
Group 2 received Risperidone (2 to 8 mg, per day) for 3 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi psychiatric hospital
Full name of responsible person
Dr Reza Daneshmand
Street address
Zip code: 1985713834, University of Social Welfare and Rehabilitation Sciences, Koodakyar Street, Daneshjoo Blv, Evin, Tehran, Iran, Islamic Republic Of
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Hamid Reza Khankeh
Street address
Zip code: 1985713834, University of Social Welfare and Rehabilitation Sciences, Koodakyar Street, Daneshjoo Blv, Evin, Tehran, Iran, Islamic Republic Of
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of University of Social Welfare and Rehabilitation 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
Mashhad University of Medical sciences
Full name of responsible person
Dr Roya Samadi
Position
Psychiatrist
Other areas of specialty/work
Street address
Zip code: 91959, Ibn e Sina Hospital, Hor-e-Ameli blv, Mashhad, Khorasan Razavi,
City
Mashhad
Postal code
Phone
+98 517112701
Fax
Email
samadiroya10@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical sciences
Full name of responsible person
Dr Roya Samadi
Position
Psychiatrist
Other areas of specialty/work
Street address
Zip code: 91959, Ibn e Sina Hospital, Hor-e-Ameli blv, Mashhad, Khorasan Razavi,
City
Mashhad
Postal code
Phone
+98 51 3711 2701
Fax
Email
samadiraya10@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Roya Samadi
Position
Psychiatrist
Other areas of specialty/work
Street address
Zip code: 91959, Ibn e Sina Hospital, Hor-e-Ameli blv, Mashhad, Khorasan Razavi,
City
Mashhad
Postal code
Phone
+98 51 3711 2701
Fax
Email
royasamadi10@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)