The purpose of this study is to evaluate the effects of haloperidol versus diazepam in improving the clinical symptoms in patients with conversion disorder according to DSM IV criteria referred to emergency room. Patients who are referred to Imam Hossein hospital emergency room will be the population of this study. The total sample size will be 168 patients, including four groups of men and women with and without history of psychiatric illness. Groups will be matched for sex and history of psychiatric illness. All patients with conversion disorder according to DSM IV criteria who are referred to emergency room will be included in this study. However, patients with abnormal vital signs; illness; under 18 years; over 60 years; pregnant; addicted patients and those who are not willing to participate in this study will be excluded. Eligible patients who signed a consent form to participate and received a questionnaire to answer the following questions regarding to personal data, underlying diseases, history of psychiatric illness, drug history, recovery and discharge time. These patients will randomly receive an injection two doses (5 mg and 5-10 mg ) of either haloperidol or diazepam by a nurse who would not communicate with the physicians involved . The patients will be monitored during the course of treatment and symptoms such as time of recovery and possible complications will be recorded by a physician. The patients will be follow up a week and any possible complications will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108317449N1
Registration date:2012-06-23, 1391/04/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-06-23, 1391/04/03
Registrant information
Name
Majid Shojaee
Name of organization / entity
Shahid Beheshti Medical University
Country
Iran (Islamic Republic of)
Phone
+98 21 7343 2380
Email address
m.shojaee@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti Medical University
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intravenous Haloperidol against intravenous Diazepam in improving conversion disorder in the emergency room
Public title
Intravenous Haloperidol efficacy in improving conversion disorder patients in emergency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients with conversion disorder according to DSM IV criteria referred to emergency room.
Exclusion criteria: Patients with abnormal vital signs; ill; under 18; over 60; pregnant patients; opium addicted patients; Unwillingness to cooperation
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
168
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
Shahid Beheshti Medical University, Medical School, Ethics Committee
Street address
Shahid Beheshti Univercity of Medical Science and Health Care, Medical School, Koodakyar Deadlock, Yemen St, Chamran Highway
City
Tehran
Postal code
Approval date
2012-04-29, 1391/02/10
Ethics committee reference number
90-1-134-8723-8303
Health conditions studied
1
Description of health condition studied
conversion disorder
ICD-10 code
F44
ICD-10 code description
Dissociative [conversion] disorders
Primary outcomes
1
Description
The patient feel better
Timepoint
Before the intervention, one hour after the intervention and one week after intervention
Method of measurement
Standardized questionnaire, the patients feel better, better expressed by the patient and his companions
2
Description
The patient's symptoms disappear
Timepoint
Before the intervention, one hour after the intervention and one week after intervention
Method of measurement
Standardized questionnaire, the patients feel better, better expressed by the patient and his companions
Secondary outcomes
1
Description
Drug side effects
Timepoint
Just after the intervention until a week later
Method of measurement
Questionaire, Physical exam
2
Description
Worsening of the patient
Timepoint
Just after the intervention until a week later
Method of measurement
Questionaire, Physical exam
3
Description
Treatment failure
Timepoint
Just after the intervention to one hour after the start of intervention
Method of measurement
Physical examination
Intervention groups
1
Description
Haloperidol, 5mg, Intravenous
Category
Treatment - Drugs
2
Description
Diazepam, 5-10mg, Intravenous
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam hossein Medical & Educational Center
Full name of responsible person
Dr Majid Shojaee
Street address
Emam hossein Medical & Educational Center, Shahid Madani st.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti Medical University
Full name of responsible person
Mrs Tadaion
Street address
Shahid Beheshti Univercity of Medical Science and Health Care, Medical School, Koodakyar Deadlock, Yemen St, Chamran Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti Medical University
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
Shahid Beheshti Medical University
Full name of responsible person
Dr Majid Shojaee
Position
Assistant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Emam Hossein Medical & Educational Center, Shahid Madani st.
City
Tehran
Postal code
Phone
+98 21 7343 2380
Fax
Email
m.shojaee@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Medical University
Full name of responsible person
Dr Majid Shojaee
Position
Assistant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Emam hossein Medical & Educational Center, Shahid Madani st.
City
Tehran
Postal code
Phone
+98 21 7343 2380
Fax
Email
m.shojaee@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti Medical University
Full name of responsible person
Dr Majid Shojaee
Position
Assistant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Emam hossein Medical & Educational Center, Shahid Madani st.
City
Tehran
Postal code
Phone
+98 21 7343 2380
Fax
Email
m.shojaee@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)