1. Home
  2. Approved trials
  3. » فارسی

The effectiveness of adding modafinil drug on negative symptoms of schizophrenic patients being treated with risperidone or olanzapine

Protocol summary

Study aim
The effectiveness of adding modafinil drug on negative symptoms of schizophrenic patients being treated with risperidone or olanzapine
Design
The clinical trial study includes two intervention and control groups, 21 people in each group are randomly assigned. The method used is block randomization.
Settings and conduct
This study will be conducted on patients hospitalized in Ahvaz Golestan Hospital. The patients and the evaluator do not know the type of medicine received.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients between 18 and 65 years old, schizophrenic patients who have been treated with risperidone or olanzapine, patients diagnosed with schizophrenia based on DSM-5 criteria. Exclusion criteria: taking typical antipsychotic and atypical antipsychotic drugs except risperidone and olanzapine and antidepressants and sodium valproate and lithium and benzodiazepines, presence of accompanying psychiatric disorders such as schizoaffective or other psychotic disorders, bipolar disorder, anxiety disorders such as panic disorder or Obsessive-compulsive disorder, post-traumatic stress disorder, eating disorder, dependence or abuse of substances, drugs or alcohol acutely or in the past 12 months, except for nicotine, sensitivity to modafinil or any of the placebo compounds.
Intervention groups
Intervention group: in the intervention group, patients will receive 100 to 200 mg of modafinil tablets per day for 4 weeks in addition to the prescribed antipsychotic treatment (resperidone or olanzapine) that they were already taking. Control group: in the control group, in addition to prescribed antipsychotic treatment, the patients were given a placebo pill that is similar to Modafinil in terms of shape, smell, taste, size and color and was prepared by the Ahvaz University in the same way as the intervention group will receive
Main outcome variables
Negative symptoms

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161228031626N6
Registration date: 2023-07-15, 1402/04/24
Registration timing: prospective

Last update: 2023-07-15, 1402/04/24
Update count: 0
Registration date
2023-07-15, 1402/04/24
Registrant information
Name
Hatam Boostani
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3038
Email address
tabibi.y@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-01, 1402/05/10
Expected recruitment end date
2023-10-02, 1402/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of adding modafinil drug on negative symptoms of schizophrenic patients being treated with risperidone or olanzapine
Public title
The effectiveness of adding modafinil drug on negative symptoms of schizophrenic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with schizophrenia based on DSM-5 criteria Schizophrenic patients who have been treated with risperidone or olanzapine.
Exclusion criteria:
Taking typical antipsychotic and atypical antipsychotic drugs, except for risperidone and olanzapine, and antidepressants, sodium valproate, lithium, and benzodiazepines. The presence of accompanying psychiatric disorders such as schizoaffective or other psychotic disorders, bipolar disorder, anxiety disorders such as panic disorder or obsessive-compulsive disorder, post-traumatic stress disorder, eating disorder Dependence or abuse of substances, drugs or alcohol, acutely or in the past 12 months, except for nicotine Allergy to Modafinil or any of the placebo ingredients
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
In order to divide patients into two groups, the randomized block method is used. In this method, group A is related to the intervention and group B is considered as the control and is classified into 4 blocks including AABB, ABAB, ABBA, BBAA, BABA, BAAB, according to the selected permutations. The patient is classified into one of the intervention or control groups. Random allocation software was used for randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the project manager and the patient are unaware of which of the two groups will receive which drug or placebo. Medicines and placebos will be similar in terms of shape, color, smell and taste.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of ahvaz University of Medical Sciences
Street address
Ahvaz Jondishapur University of Medical Sciences, Esfand ave, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2023-07-03, 1402/04/12
Ethics committee reference number
IR.AJUMS.REC.1402.216

Health conditions studied

1

Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia

Primary outcomes

1

Description
Negative symptoms
Timepoint
Before and 4 weeks after the study
Method of measurement
Scale for Assessment of Negative Symptoms (SANS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, patients will receive 100 to 200 mg of modafinil per day for 4 weeks in addition to the prescribed antipsychotic treatment (resperidone or olanzapine) they were already taking.
Category
Treatment - Drugs

2

Description
Control group: In this group, in addition to the prescribed antipsychotic treatment, the patients were given a placebo pill that was similar to Modafinil in terms of shape, smell, taste, size and color and was prepared by the Faculty of Pharmacy of Ahvaz University in the same way as the intervention group for 4 weeks will receive
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Golestan hospital
Full name of responsible person
Maryam Khalafi
Street address
Golestan Hospital, Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
peymann_600@mail.ru

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Email
zakerkish.m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Hatam Boostani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
boostani-h@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hatam Boostani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
boostani-h@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Khalafi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
peymann_600@mail.ru

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
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...