The evaluation of atypical antipsychotic augmentation with Atomoxetine in the reduction of negative symptoms in Patients with Schizophrenia
Design
The study is a randomized double blind clinical trial with community based and pragmatic control group, with parallel groups design. There will be 30 patients in each group. Randomization is done by permutation block method. Patients and evaluators do not know the type of medication receiving by each group.
Settings and conduct
In this double-blind clinical trial, 60 patients will enter the study. The patients will be selected from the patients who will be admitted to the psychiatric ward or referred to the psychiatric clinic of the Ahvaz Golestan Hospital with schizophrenia dignosis and their disease will be confirmed by a psychiatrist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Detection of schizophrenia based on the diagnosis of a psychiatrist who is a faculty member and an psychiatry assistant through a clinical interview based on DSM-5; Bold negative symptoms (PANSS negative symptom sub-scale score more than 15); Not having liver disease; Become as a schizophrenia patients for more than 1 year; Age range between 18 and 70 years. Exclusion criteria: Presence of Depression based on DSM-5 Clinical Interview; Presence of Bipolar disorder; Pregnant or lactating woman; Substance abuse during the last month; patients suffering from Attention Deficit Hyperactivity Disorder (ADHD).
Intervention groups
Intervention group: A group of 30 patients will receive atomoxetine 40 mg daily in the first week and then 80 mg daily in the following weeks until the 8th week. The effect of the medication on the negative symptoms from the perspective of negative signs and overall scores will be compared with the PANSS scale at the onset of the treatment, and the 4th and 8th weeks.
Control group: This group will receive placebo tablets which will be similar to atomeboxin in shape, color, odor, and taste.
Main outcome variables
lack of social interest; Frivolity; Anhedonia; loss of motivation,
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100520003979N9
Registration date:2018-10-19, 1397/07/27
Registration timing:prospective
Last update:2018-10-19, 1397/07/27
Update count:0
Registration date
2018-10-19, 1397/07/27
Registrant information
Name
Forugh Riahi
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3038
Email address
riahi-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of atypical antipsychotic augmentation with Atomoxetine in the reduction of negative symptoms in patients with Schizophrenia
Public title
Evaluation the effect of atypical antipsychotic augmentation with Atomoxetine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Detection of schizophrenia based on the diagnosis of a faculty psychiatrist and an psychiatrist assistant with a clinical interview based on DSM-5
Bold negative symptoms( PANSS negative symptom sub-scale score more than 15)
Not having liver disease
Suffering from the disease for more than a year
Age between 18 and 70 years.
Exclusion criteria:
Presence of Depression based on DSM-5 Clinical Interview
Presence of Bipolar disorder
Pregnant or lactating woman
Substance abuse during the last month
patients suffering from Attention Deficit Hyperactivity Disorder (ADHD)
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the method of the permutation blocks of size 4, individuals are randomly divided into two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The placebo is similar to atmoxtein in shape, color, smell and taste and will be available at the Faculty of Pharmacy, Ahwaz University of Medical Sciences. The medication will be prescribed by the assistants and given to the patients by the nurses at psychiatric ward. The project executor is not aware of the prescriptions in each group. Also, the patient is not aware of the type of medicine takes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd, Ahvaz, Khoozestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-09-22, 1397/06/31
Ethics committee reference number
IR.AJUMS.REC.1397.416
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Lack of social interest
Timepoint
At the beginning of the treatment and at 4th and 8th weeks
Method of measurement
PANSS scale
2
Description
Frivolity
Timepoint
At the beginning of the treatment and at 4th and 8th weeks
Method of measurement
PANSS scale
3
Description
Anhedonia
Timepoint
At the beginning of the treatment and at 4th and 8th weeks
Method of measurement
PANSS scale
4
Description
Loss of motivation
Timepoint
At the beginning of the treatment and at 4th and 8th weeks
Method of measurement
PANSS scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Atomoxetine is given 40 mg daily in the first week and 80 mg daily in the following weeks until 8 weeks. The effect of the medication on the negative symptoms in the two groups is compared with the PANSS scale at the start of the treatment and the weeks 4th and 8th for negative signs and the overall score scales.
Category
Treatment - Drugs
2
Description
Control group: This group will receive placebo which is similar to Atomoxtein in shape, color, smell, and taste.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Adolecent and child Psychiatry Clinic, Golestan Hospital
Full name of responsible person
Forugh Riahi
Street address
Ahvaz Golestan Hospital, Golestan Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
Riahi13@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ahvaz Junishapur University of Medical Science,Farvardin Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
badavi.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
Forough Riahi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Golestan hospital,Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
Riahi13@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Erfanifar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Golestan hospital,Golestan Blvd
City
َAhvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
Alidorostghol@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Erfanifar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Golestan hospital,Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
alidorotghol@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