Protocol summary

Study aim
Assessment of the efficacy and safety of adding Nano-Curcumin to antipsychotic treatment regimen in improving positive, negative, general and cognitive symptoms in patients with chronic schizophrenia
Design
A randomized, double-blind, placebo-controlled clinical trial, design of 40 patients with chronic schizophrenia (1: 1 in each group) at 4 months
Settings and conduct
Care centers in Mazandran province
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-65 years old men with the diagnosis of schizophrenia based on DSM-5 criteria for at least two years and despite the anti-psychotic drug treatment, they are still symptomatic. They are treated with antipsychotics for at least one year and In the last month, the type and dosage of their antipsychotic drugs remain constant. If receiving medications such as mood stabilizer or anti depressants, their type and dosage will remain constant from one month before the start of the study and during the study.
Intervention groups
Intervention group: standard treatment regimen with two nanocurcumin capsule 80mg (sinacurcumin@) that produced by the Nanotechnology Research Center of Mashhad University of Medical Sciences and distributed by Exir Nano Sina Company in Tehran, in two divided dose. Control group: standard regimen with two placebo capsule that are similar to nanocurcumin capsules for odor, taste, size and color in two divided dose.
Main outcome variables
Assessment of PANSS; Calgary Depression Scale for Schizophrenia; CGI-I; CGI-S; Brief Assessment of Cognition in Schizophrenia (BACS) at baseline and at the end of each months. Assessment of safety by using weekly BARS, SAS and AIMS Scales. Check of the profile lipid and fasting blood glucose at baseline and end of study. Measuring patient weight at the beginning of the study and the end of each month.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120314009297N5
Registration date: 2018-05-14, 1397/02/24
Registration timing: registered_while_recruiting

Last update: 2018-05-14, 1397/02/24
Update count: 0
Registration date
2018-05-14, 1397/02/24
Registrant information
Name
narjes hendouei
Name of organization / entity
mazandaran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 911 327 0107
Email address
hendoieen@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the efficacy and safety of nano curcumin as an adjuvant to antipsychotics in male patients with residual schizophrenia: A randomized, double-blind, placebo-controlled trial
Public title
The effect of nano curcumin in male patients with residual schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-65 years old men With the diagnosis of schizophrenia based on DSM-5 criteria for at least two years and despite the anti-psychotic drug treatment, they are still symptomatic. They are treated with antipsychotics for at least one year and In the last month, the type and dosage of their antipsychotic drugs remain constant. If receiving medications such as mood stabilizer or anti depressants, their type and dosage will remain constant from one month before the start of the study and during the study.
Exclusion criteria:
Patients with acute suicidal behavior or history of suicide attempt last year, the presence of psychiatric disorders such as schizoaffective or other psychotic disorders, Mental retardation or other cognitive impairment, bipolar disorder and depression, anxiety disorders such as current panic disorder or obsessive-compulsive disorder, post traumatic stress disorder, eating disorder. History of drug dependence (DSM-5 drug dependency criterion) or substance abuse during the three months prior to the onset of the study or positive urine specimen testing at the start of the study. ECT therapy in the past six months. People with thoughts or attempted to harm themselves or others at baseline and at 6 months before the start of the study. Mental retardation Patients with neurological disorders such as uncontrolled seizure, dementia, head injury, seizure disorder (other than febrile) and neurodegenerative diseases (such as Alzheimer's disease, Parkinson's disease, stroke, and multiple sclerosis) Patients with uncontrolled illnesses such as cardiovascular disease-liver and kidney failure-types of malignancies-autoimmune diseases, endocrine disorders such as diabetes, and hematological disorders, chronic diseases such as cardiovascular disease, history of myocardial infarction, severe hypertension, excessive overweight due to endocrine disorder, unstable thyroid disease, biliary diseases, consuming sex hormones, cerebrovascular diseases, benign prostatic hypertrophy, glaucoma, asthma, COPD, chronic fatigue syndrome, Fibromyalgia and any unstable medical condition. Receiving anticoagulant and antiplatelet treatments or having hemorrhagic risk factors, having an infectious disease during last month, the likelihood of not being able to complete a study because of a serious illness. No more than once a week to take analgesics and do not use turmeric and curcumin supplements and no use of turmeric in the diet. Sensitivity to the curcumin plant or any of the available placebo compounds. History of NMS Patients treated with anticholinergic drugs (except of biperiden and trihexyphenidyl) according to drugs on the Anticholinergic Burden scale (ACB)
Age
From 18 years old to 65 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Based on random numbers and 1: 1 ratio in treatment group and control group
Blinding (investigator's opinion)
Double blinded
Blinding description
Curcumin and placebo capsules are completely similar in terms of color, size, smell and taste produced by a completely similar manufacturing and packagings. Patients were randomly tested in groups. Until the end of the study, no patient or study persons are aware of which drug the patient receives. And anybody other than those who are defective in the study is aware.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی مازندران
Street address
Moallem street, Moallem square, Vice chancellor for research
City
Sari
Province
Mazandaran
Postal code
33971-48157
Approval date
2018-04-18, 1397/01/29
Ethics committee reference number
IR.MAZUMS.REC.97.83

Health conditions studied

1

Description of health condition studied
Schizophrenia with residual symptoms
ICD-10 code
F20.5
ICD-10 code description
Residual schizophrenia

Primary outcomes

1

Description
Score of general, positive and negative symptoms with Positive and Negative Symptom Scale (PANSS)
Timepoint
At baseline and the end of each month
Method of measurement
Positive and Negative Symptom Scale (PANSS)

Secondary outcomes

1

Description
Score of change in severity of illness based on Clinical Global Impression – Improvement (CGI-I)
Timepoint
At baseline and the end of each month
Method of measurement
Clinical Global Impression -Improvement (CGI-I) score

2

Description
Score of severity of illness based on Clinical Global Impression of Severity (CGI-S)
Timepoint
At baseline and at the end of each months
Method of measurement
Clinical Global Impression off Severity (CGI-S)

3

Description
Score of depression symptoms based on Calgary Depression Scale for Schizophrenia
Timepoint
At baseline and the end of each month
Method of measurement
Calgary Depression Scale for Schizophrenia

4

Description
Score of improvement in cognitive symptoms based on Brief Assessment of Cognition in schizophrenia
Timepoint
At baseline and the end of the each months
Method of measurement
Brief Assessment of Cognition in schizophrenia

5

Description
Score of SAS for extra pyramidal side effects
Timepoint
At baseline and weekly
Method of measurement
Simpson-Angus Scale (SAS)

6

Description
Score of Barnes Akathisia Rating Scale (BARS)
Timepoint
At baseline and weekly
Method of measurement
Barnes Akathisia Rating Scale (BARS)

7

Description
Score of Abnormal Involuntary Movement Scale (AIMS)
Timepoint
At baseline and weekly
Method of measurement
Abnormal Involuntary Movement Scale (AIMS)

8

Description
Lipid profile
Timepoint
At baseline and the end of study
Method of measurement
ELIZA Kit

9

Description
Fasting blood glucose
Timepoint
At baseline and the end of study
Method of measurement
ELIZA Kit

10

Description
Weight
Timepoint
At baseline and the end of each month
Method of measurement
Scale

Intervention groups

1

Description
Intervention group: Standard treatment regimen with two nanocurcumin capsule 80mg (sinacurcumin@) in two divided dose for four months.
Category
Treatment - Drugs

2

Description
Control group: Standard treatment regimen with two placebo capsule that are similar to nanocurcumin capsules for odor, taste, size and color in two divided dose.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Psychiatric care centers in Mazandaran province
Full name of responsible person
Narjes Hendouei
Street address
Farvardin care center, Alivac, Farah Abad Blvd.
City
Sari
Province
Mazandaran
Postal code
33971-48157
Phone
+98 11 3354 2472
Email
Hendoieen@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Moallem street, Moallem square-Vice chancellor for research
City
Sari
Province
Mazandaran
Postal code
33971-48157
Phone
+98 11 3326 1245
Email
tmaae@liv.ac.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Narjes Hendouei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Clinical pharmacy
Street address
20th Km Farahabad Road, Payambar Azam Academic Complex
City
Sari
Province
Mazandaran
Postal code
33971-48157
Phone
+98 11 3354 2472
Email
hendoieen@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Narjes Hendouei
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Clinical pharmacy
Street address
20th Km Farahabad Road, Payambar Azam Academic Complex
City
Sari
Province
Mazandaran
Postal code
33971-48157
Phone
+98 11 3354 2472
Email
hendoieen@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Narjes Hendouei
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Clinical pharmacy
Street address
20th Km Farahabad Road, Payambar Azam Academic Complex
City
Sari
Province
Mazandaran
Postal code
33971-48157
Phone
+98 11 3354 2472
Email
hendoieen@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
I have not decided yet - its release plan is still unclear
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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