Study of effect of Atomoxetine on cognitive symptoms in patients with schizophrenia
Design
42 schizophrenic patients were divided into two groups of intervention and control through block randomization.Randomized, triple-blind, placebo-controlled, single-center, phase II trial.
Settings and conduct
The study was conducted at Clinic of Psychiatry of the University Hospital Ibn.e.Sina and Dr. Hejazi, Mashhad. patient was diagnosed with schizophrenia aged 18-60 years are evaluated based on the inclusion and exclusion criteria and only patients who meet these criteria are selected. as a triple blind (the patient, elevator and physician and data analyses will all be blind and the medication and placebo in envelopes A and B will be given by the nurse).
Participants/Inclusion and exclusion criteria
Inclucion criteria: Use Antipsychotic Generation 2 Drug -Lack of dementia- Not taking other medicines (except anticholinergics and benzodiazepines)- No pregnancy or breastfeeding- There is no recent history of drugs (except nicotine)- schizophrenic patients during partial recovery.
Exclusion criteria: Drug side effects including: abdominal discomfort, loss of appetite resulting in weight loss, dizziness, irritability and mood swings- Occurrence of drug interactions with patient medications.
Intervention groups
Intervention group: Patients are given 40 mg of automoxetine daily for 4 weeks and then 80 mg for another 4 weeks. Control group: Control group is given placebo according to the same protocol. Placebo is manufactured and prepared by the Mashhad School of Pharmacy.
Main outcome variables
cognitive function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101130005280N31
Registration date:2019-12-21, 1398/09/30
Registration timing:registered_while_recruiting
Last update:2019-12-21, 1398/09/30
Update count:0
Registration date
2019-12-21, 1398/09/30
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of Atomoxetine in comparison with placebo on cognitive symptoms in patients with schizophrenia
Public title
Study of the effect of Atomoxetine on cognitive symptoms in patients with schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
2nd Generation Antipsychotic Drug use
Lack of dementia
Not taking other medicines (except anticholinergics and benzodiazepines)
No pregnancy or breastfeeding
There is no recent history of drugs (except nicotine)
schizophrenic patients during partial recovery
Exclusion criteria:
Drug side effects including: abdominal discomfort, loss of appetite resulting in weight loss, dizziness, irritability and mood swings
Occurrence of drug interactions with patient medications
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization We can create a block to assign sample numbers equally to each group. If block size is two, we can make two possible sequences of AB and BA. based on arrangement allocated participants to a treatment and control groups with sealed envelope
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Building Ghoreshi, Central Organization of Mashhad University of Medical Sciences, Daneshgah Avenue, Mashhad, Iran.
City
mashhad
Province
Razavi Khorasan
Postal code
1394491388
Approval date
2019-04-16, 1398/01/27
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.170
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F00-F98
ICD-10 code description
اختلالات رفتاری و روانی
Primary outcomes
1
Description
Cognitive function
Timepoint
Before intervention, end of first and second
Method of measurement
PANSS،Wisconsin، Stroop، Digit Span Questionier
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients are given 40 mg of automoxetine is given daily by Tadbir Kala Jam Pharmaceutical Company for 4 weeks and then 80 mg for another 4 weeks.
Category
Treatment - Drugs
2
Description
Control group is given placebo according to the same protocol. Placebo is manufactured and prepared by the Mashhad School of Pharmacy