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Comparing the Efficacy of Aripiprazole with other Second-Generation Antipsychotics in Acute Mania Symptoms in Manic Patients

Protocol summary

Study aim
Comparing the efficacy of aripiprazole with other second-generation antipsychotics in suppressing acute mania symptoms.
Design
This assessment is a clinical trial in phase 4; patients diagnosed with mania and with acute mania symptoms and confirmed by a psychiatrist are considered as a study group. In this study, 50 patients who have the inclusion criteria, were selected. Patients are classified into two groups by randomization and blocking method, 25 patients in the Aripiprazole group and 25 patients in the second-generation anti psychotic group. Accordingly, at the beginning of the diagnosis, and at 2, 4 and 6 weeks, the status of symptoms of acute Mania is assessed using questionnaires.
Settings and conduct
This study was conducted as a clinical trial in the psychiatric clinic of the Amir Kabir Hospital in Arak. It will also be a one-blind study in which patients will be blinded.
Participants/Inclusion and exclusion criteria
For the purpose of this study, 50 patients with bipolar disorder are required. Patients with bipolar disorder who are referred to Amir Kabir Hospital, aged over 18, are considered as inclusion criteria. The exclusion criteria also include dissatisfaction with participation in the study.
Intervention groups
In the intervention group, treatment with aripiprazole is initiated at baseline dose of 5 to 15 mg per day, after two weeks the dose can be increased to 5 mg, as well as at weeks 4 and 6, this can be 5 mg per day is added to treat them to reach 30 mg per day at the end of 6 weeks. Also in control group, used second-generation anti-psychotic , the drugs used include risperidone, olanzapine, quetiapine and sodium valproate.
Main outcome variables
Symptoms of acute mania

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110819007373N8
Registration date: 2018-12-29, 1397/10/08
Registration timing: registered_while_recruiting

Last update: 2018-12-29, 1397/10/08
Update count: 0
Registration date
2018-12-29, 1397/10/08
Registrant information
Name
Hamidreza Jamilian
Name of organization / entity
Arak University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1222 5758
Email address
jamilian.hr@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-05, 1397/09/14
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Efficacy of Aripiprazole with other Second-Generation Antipsychotics in Acute Mania Symptoms in Manic Patients
Public title
Effectiveness of Aripiprazole in Acute Mania
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with bipolar I disorder in the phase of mania Age older than 18 years Satisfaction for the study
Exclusion criteria:
Patients who have used anti-psychotic medicines for the past 30 days Patients who have been using ECT for the past 6 months Patients who are pregnant or breast-feeding Patients with alcohol dependence Cognitive impairment other than bipolar disorder High risk of suicide The use of medication stabilizers other than sodium valproate liver disorders The history of polycystic ovaries Thrombocytopenia
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
  • Participant
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomization we will use the block method, Accordingly, the patients under study are divided into two groups. The allocation of patients in two groups was based on demographic characteristics and their matching. Based on this, after considering the patients' demographic data, patients were divided into two equal groups of patients, they enrolled in the study and performed desired intervention on them.
Blinding (investigator's opinion)
Single blinded
Blinding description
This means that patients in groups do not know the used drugs, and drugs has similar packaging.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Basij Square
City
Arak
Province
Markazi
Postal code
3881173533
Approval date
2018-09-22, 1397/06/31
Ethics committee reference number
IR.ARAKMU.REC.1397.149

Health conditions studied

1

Description of health condition studied
Manic
ICD-10 code
F30.1
ICD-10 code description
Manic episode without psychotic symptoms

Primary outcomes

1

Description
Symptoms of acute mania
Timepoint
Initially and 2, 4 and 6 weeks.
Method of measurement
Using Yang Mania Rating Scale (YMRS), Clinical Global Impression Questionnaire (CGI) and Young Mania Rating Scale (YMRS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Aripiprazole is used in these patients, initiating treatment with aripiprazole at a dose of 5 to 15 mg per day, after two weeks, the dose is increased to 5 mg, also at 4 and 6 weeks it also added 5 mg daily for treatment to reach 30 mg per day at the end of 6 weeks.
Category
Treatment - Drugs

2

Description
Control group: In these patients, second-generation antipsychotic therapy is initiated with risperidone 2-3 mg once daily to a maximum of 6 mg per day, with an increase in the dose not to be greater than 1 mg per day and at intervals Less than 24 hours. Starting treatment with olanzapine is 10-15 mg per day, which can increase to 20-25 mg per day. Initiation of quetiapine treatment is 100 mg daily in divided doses. Increasing to 100 mg daily to 400 mg daily in divided doses on day 4 and on days 5 and 6 daily increases to 200 mg to 800 mg per day. Sodium valproate orally at a dose of 250 mg per day, which can be increased to 250 mg three times a day within 3 to 6 days, ultimately increasing to 1200-1500 mg daily in split doses.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Kabir Hospital
Full name of responsible person
Hamidreza Jamilian
Street address
Parastar Square
City
Arak
Province
Markazi
Postal code
3818718781
Phone
+98 86 3313 4717
Email
jamilian.hr@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Arash Anoushirvani
Street address
Vice Chancellor for Research, Arak University of Medical Sciences, Sardasht, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
jamilian.hr@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Hamidreza Jamilian
Position
Board of Psychiatry,Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Amir-Kabir Hospital, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
jamilian.hr@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
HamidReza Jamilian
Position
Board of Psychiatry,Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Amir-Kabir Hospital, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 918 161 8542
Fax
Email
jamilian.hr@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hamidreza Jamilian
Position
Board of Psychiatry ,Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Amir-Kabir Hospital, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
jamilian.hr@arakmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be 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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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