Protocol summary

Study aim
Study of the efficacy and safety of varenicline as an adjuvant to antipsychotics in patients with schizophrenia on cognitive impairment : A randomized control trial
Design
A randomized, double-blind, placebo-controlled clinical trial, design of 96 patients with chronic schizophrenia at 2 months
Settings and conduct
Care centers in Mazandran province
Participants/Inclusion and exclusion criteria
Patients who are hospitalized in psychiatric centers of the province and are in the range of 18-65 years old. Patients who were diagnosed with schizophrenia based on DSM-5 criteria, got at least two years of anti-psychotic drug treatment but still show symptoms. Patients who are treated with anti-psychotics for at least one year and in the last month, the type and the dosage of anti-psychotics has remained permanent. If the patients receives mood stabilizer drugs and antidepressants with their anti-psychotic treatment, the type and the dosage of the drug will remain constant for one month before the study and during the study.
Intervention groups
Intervention group: treatment regimen with varenicline tablet 0.5 mg daily the first 3 days then 0.5mg bid from 4th day until 7th day and then 1mg varenicline at morning and 0.5 mg at night until 9th day and after 10th day,1mg, bid until 2 months. Control group: treatment regimen with placebo tablets that are similar to varenicline tablets for odor, taste, size and color in the dose of varenicline administration.
Main outcome variables
Assessment of PANSS; BACS( brief assessment of cognition in schizophrenia; CGI-I; CGI-S; at baseline and at the end of each months. Assessment of safety by using weekly BARS, SAS and AIMS Scales.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20101108005138N4
Registration date: 2019-07-08, 1398/04/17
Registration timing: retrospective

Last update: 2019-07-08, 1398/04/17
Update count: 0
Registration date
2019-07-08, 1398/04/17
Registrant information
Name
Abbas Masoudzadeh
Name of organization / entity
Mazandaran Uiversity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15133241889
Email address
amasoudzadeh@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-22, 1397/06/31
Expected recruitment end date
2019-01-19, 1397/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the efficacy and safety of varenicline as an adjuvant to antipsychotics in patients with schizophrenia on cognitive impairment : A randomized control trial
Public title
Evaluation of Varenicline on cognitive impairement in patient with schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are hospitalized in psychiatric centers of the province and are in the range of 18-65 years old. Patients who were diagnosed with schizophrenia based on DSM-5 criteria, got at least two years of anti-psychotic drug treatment but still show symptoms. Patients who are treated with anti-psychotics for at least one year and in the last month, the type and the dosage of anti-psychotics has remained permanent. If the patients receives mood stabilizer drugs and antidepressants with their anti-psychotic treatment, the type and the dosage of the drug will remain constant for one month before the study and during the study. Consent from patient's guardian.
Exclusion criteria:
Patients with suicidal thoughts and acute suicidal behavior, a history of suicidal thoughts or attempted suicide during the past year, patients with thoughts or attempts to harm themselves or others at the beginning of the study or 6 months before the study, serious illness, major depression during the last 12 months that requires treatment, a history of hospitalization due to the episode of major depression over the past 6 months. Patients who received ECT during the last 6 months. Patients who suffer from psychiatric disorders such as schizophrenia or other psychiatric disorders' bipolar disorder, anxiety disorders such as panic disorder or obsessive-compulsive disorder, post traumatic stress disorder, eating disorder. Current or past (past 6 months) diagnosis, severe personality disorders that compromise the ability of participants to fulfill the study requirements Dependence or acute drug, substance or alcohol abuse in the past 12 months, except nicotine (DSM-5) or positive urine specimen testing at the beginning of the study Acute phase of the disease ((an increase of 20% in the total score of PANSS) criteria for assessing the positive and negative symptoms of schizophrenia) Sensitization to varenicline or other substances in the placebo Other treatments that can interfere with the results. for example quit smoking (bupropion, varicellin or nicotine), the use of varnicline and other medication less than 30 days before the study or during the study. patients treated with anticholinergic drugs (except bipyridine and trihexafenidil) based on ACB scale (26) and obtaining the history of the drugs patient used. Physical illness, mental retardation or other cognitive impairment and neurological disorders such as delirium dementia, uncontrolled bleeding, head injury, seizure disorder (other than the febrile type), and neurodegenerative diseases (such as Alzheimer's, Parkinson's disease , Stroke, and multiple sclerosis), and severe cardiovascular or pertussocular ailments in the past 6 months, recent history of cancer (in the past 5 years), BMI less than 15 kg/m2 or more than 38 kg/m2 or weight more than 45.5 kg or any severe and unstable medical or psychiatric conditions and disorders. uncontrolled ilnesses and patients with NMS. this information can be obtained through PMH.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 96
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
varenicline and placebo tablets 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
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Moallem street, Moallem square, Vice chancellor for research
City
Sari
Province
Mazandaran
Postal code
33971-48157
Approval date
2018-10-02, 1397/07/10
Ethics committee reference number
IR.MAZUMS.REC.1398.585

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 improvement in cognitive symptoms based on brief assesment of cognition in schizophrenia
Timepoint
At baseline and the end of each month
Method of measurement
Brief assessment of Cognition in schizophrenia

Intervention groups

1

Description
Intervention group: treatment regimen with varenicline tablets begin with 0.5 mg at first 3 day and then increase to 0.5 mg bid at the second 3 days and then reach to 1mg at morning and 0.5 mg at night for the third 3 days and from the 10th day, 1mg bid until the end of 2nd month.
Category
Treatment - Drugs

2

Description
Control group: treatment regimen with placebo tablets with the same protocol dose that use for varenicline. The placebo tablets are similar to varenicline tablets for odor, taste, size and color.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Psychiatric care centers in Mazandaran province
Full name of responsible person
Abbas Masoudzadeh
Street address
Farvardin care center, Alivac, Farah Abad Blvd.
City
Sari
Province
Mazandaran
Postal code
33971-48157
Phone
+98 11 3354 2472
Email
masoudzadeh@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
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?
No
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
60
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
Abbas Masoudzadeh
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
20th Km Farahabad Road, Payambar Azam Academic Complex
City
Sari
Province
Mazandaran
Postal code
33971-48157
Phone
+98 11 3354 2472
Email
masoudzadeh@yahoo.com

Person responsible for scientific inquiries

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

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Abbas Masoudzadeh
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
20th Km Farahabad Road, Payambar Azam Academic Complex
City
Sari
Province
Mazandaran
Postal code
33971-48157
Phone
+98 911 151 3058
Email
masoudzadeh@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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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