The main aim of the study is to evaluate oxidative stress and neurotrophic factors after intervention in methamphetamine associated psychosis (MAP) patients who receive Hypiran in addition to the anti psychotic medications. This study is a double blind clinical trial in two groups of patients with MAP and obtaining informed consent of patients before subjecting them to any intervention. Inclusion criteria are current methamphetamine users who have been hospitalized. Exclusion criteria comprise previous history of bipolar disorder, mania symptoms in the current context based on clinical examination, and liver and kidney diseases. Before the intervention, the patients will be investigated for liver and kidney function tests such as AST, ALT, ALP, and urea and creatinine .Eligible patients in the study are randomly placed in control and case groups. The sample size is 20 people in each group. Then the blood sample will be collected from the two groups of the patients when they are admitted to the hospital and after withdrawal of methamphetamine. After blood drowns from the patients, the intervention will be done. The case group will received 60 drops of Hypiran in three dose and the control patients will get placebo in the same dose with Hypiran. After two weeks, the blood samples will be obtained from case and control groups. Finally, after one month of intervention the blood samples will be collected again from the two groups to evaluate oxidative stress and trophic factors.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016082129447N1
Registration date:2016-10-31, 1395/08/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-10-31, 1395/08/10
Registrant information
Name
Maryam Jazayeri
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8872 6977
Email address
jazaieri.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Study of Hypiran (Hypericum Perforatum) effect on oxidative stress and neurotrophic factors in Methamphetamine associated psychosis patients
Public title
The Study of Hypiran effect on Methamphetamine associated psychosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the patients who are current methamphetamine users have been admitted to the hospital; age between 18 and 70 years old; they have met the criteria for methamphetamine induced psychotic disorder according to DSM-5.
Exclusion criteria: having a diagnosis of bipolar I and II disorder; substance induced mood disorder (with manic symptoms); liver and kidney diseases.
Age
From 18 years old to 70 years old
Gender
Male
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Postal code
Approval date
2016-10-09, 1395/07/18
Ethics committee reference number
IR.IUMS.REC.1395.27866
Health conditions studied
1
Description of health condition studied
Methamphetamine associated psychosis
ICD-10 code
F16
ICD-10 code description
Mental and behavioural disorders due to use of hallucinogens
Primary outcomes
1
Description
Glutathione Peroxidase
Timepoint
before intervention, 14 and 28 days after intervention
Method of measurement
colorimetry
2
Description
Glutathione Reductase
Timepoint
before intervention, 14 and 28 days after intervention
Method of measurement
colorimetry
3
Description
Total Antioxidant Capacity
Timepoint
before intervention, 14 and 28 days after intervention
Method of measurement
colorimetry
4
Description
Nitric Oxide
Timepoint
before intervention, 14 and 28 days after intervention
Method of measurement
Elisa
5
Description
Malondialdehyde
Timepoint
before intervention, 14 and 28 days after intervention
Method of measurement
Elisa
6
Description
selenoprotein1
Timepoint
before intervention, 14 and 28 days after intervention
Method of measurement
Elisa
7
Description
Methamphetamine
Timepoint
14 after intervention
Method of measurement
HPLC
Secondary outcomes
1
Description
BDNF
Timepoint
before intervetion and 28 days after intervention
Method of measurement
ELISA
2
Description
VEGF
Timepoint
before intervetion and 28 days after intervention
Method of measurement
ELISA
3
Description
DTNBP1
Timepoint
before intervetion and 28 days after intervention
Method of measurement
ELISA
4
Description
IL-6
Timepoint
before intervetion and 28 days after intervention
Method of measurement
ELISA
Intervention groups
1
Description
Hypiran medication will be prescribed in the intervention group. The dosage of hypiran use is 60 drops three times a day for one month. (60 drops of hypiran has 0.3 mg of the active ingredient called Hypericin).
Category
Treatment - Drugs
2
Description
Placebo will be prescribed in the control group. The dosage of placebo use is 60 drops three times a day for one month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran psychiatric Hospital
Full name of responsible person
Dr. Mehrdad Eftekhar, Dr. Seyed vahid Shariat
Street address
District 21, Azadegan Freeway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Javad Mousavi
Street address
Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Mehrdad Eftekhar
Position
MD, Faculty member
Other areas of specialty/work
Street address
Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 8670 3083
Fax
Email
mehrdad.eftekhar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Maryam Jazayeri
Position
PhD, Faculty member
Other areas of specialty/work
Street address
Hemmat high way
City
Tehran
Postal code
Phone
+98 21 8670 3176
Fax
Email
maryamjazayeri@yahoo.comjazaieri@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Maryam Jazayeri
Position
PhD, Faculty member
Other areas of specialty/work
Street address
Hemmat highway
City
Tehran
Postal code
Phone
+98 21 8670 3176
Fax
Email
maryamjazayeri@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)