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Description and comparison of autonomous nervous system function in aggressive depressed patients before and after serteralin treatment by the measurement of related biomarkers

Protocol summary

Summary
The object of the study, is the description and comparison of autonomous nervous system function in aggressive depressed patients before and after treatment by serteraline. Among visited patients at Psychology clinic of Razi Hospital in Tabriz, 50 patients who suffer from depression, are selected with the conditions of being in their first episode of disease, and no history of anti-depressive medical treatment. Throughout two questionnaire, "SCID" and "Beck", degree of depression and by questionnaire of "STAXI-2", degree of aggression are scored, then bio-markers' basic condition such as heart rate, blood pressure, respiratory rate, etc ... through a Biofeedback system are evaluated. In the next step, seteraline (Asentra) starts with initial dose of 50 mg per day (which could be raised to 100 mg per day), and at the intervals of 1.5 and 3 months, bio-markers are re-evaluated to compare the function of autonomous system with the basic states. If it confirmed that autonomous system function are abnormal in aggressive depressive patients, and after the treatment with Asentra, it becomes normalized, a common etiology could be propounded, so that autonomous modifier drugs for patients who are irresponsible to routine treatments may be suggested.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201411122999N4
Registration date: 2015-07-10, 1394/04/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-07-10, 1394/04/19
Registrant information
Name
Alireza Farnam
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5951
Email address
farnama@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University Of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Description and comparison of autonomous nervous system function in aggressive depressed patients before and after serteralin treatment by the measurement of related biomarkers
Public title
Effect of serteraline in depressed aggressive patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Depression should be confirmed by a psychologist throughout a structured interview based on DSM-IV criteria; Patient should be at 1st episode of disease, with no history of anti-depression treatment (medical or non-medical); Presence of aggressive behaviors confirmed by history or medical examination; Patient prefers taking more efficient drug, no matter how expensive; Iranian nationality; Age between 20 to 40 years old; Agreement for participating in study through signing testimonial form Exclusion criteria: History of any psychological disease, except for depression; Present history of any drug affecting CNS/PNS; History of any of these conditions: Amyloidosis, Acute porphyria, Cardiovascular/Respiratory/Endocrine/Neurologic disease, Alcohol/drug abuse, Malabsortion, Multiple sclerosis, ALS; Pre-menstural syndrome for female; Presence of genetical susceptibility to above mentioned conditions
Age
From 19 years old to 39 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Present study is of "Before after study" type.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University Of Medical Sciences
Street address
Central building No. 2, Tabriz University Of Medical Science, Golgasht street, Tabriz
City
Tabriz
Postal code
Approval date
2015-03-09, 1393/12/18
Ethics committee reference number
93196

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32.9
ICD-10 code description
Depression NOS

Primary outcomes

1

Description
Depression intensity
Timepoint
1.5
Method of measurement
Beck Questionnaire, 2nd edition

2

Description
Anger status
Timepoint
1.5
Method of measurement
STAXI Questionnaire, 2nd edition

3

Description
Heart rate variability
Timepoint
1.5
Method of measurement
Biofeedback system

4

Description
Respiratory Rate
Timepoint
1.5
Method of measurement
Biofeedback system

5

Description
Heart rate
Timepoint
1.5
Method of measurement
Biofeedback system

6

Description
Skin Temprature
Timepoint
1.5
Method of measurement
Biofeedback system

7

Description
Blood Pressure
Timepoint
1.5
Method of measurement
Biofeedback system

8

Description
Valsalva Ratio
Timepoint
1.5
Method of measurement
Biofeedback system

9

Description
Expiratory:Inspiratory ratio
Timepoint
1.5
Method of measurement
Biofeedback system

10

Description
Skin conductivity level
Timepoint
1.5
Method of measurement
Biofeedback system

Secondary outcomes

empty

Intervention groups

1

Description
At first, the patients are scored by "Beck" 2nd edition questionnaire and "Structured Clinical Interview-DSM-IV (SCID) for severity of depression, and also by "State-Trait Anger Expression Inventory-2" questionnaire (STAXI-2) for the state of aggression. Afterwards, basic states of biomarkers, including heart rate, blood pressure, respiratory rate and etc... will be measured by a bio-feedback system. Then medical treatment with serteraline (Asentra, manufactured by ACTOVERCO factory, Karaj, Iran) by initial dose of 50 mg /day, orally, starts. The dosage could raise to 100 mg/day if weekly visits indicate that clinical response is inappropriate. At the intervals of 1.5 and 3 months later, autonomous biomarkers will be re-evaluted to compared with the basic states.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Arezoo Mehrara
Street address
Tabriz, El Goli Road
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University Of Medical Science
Full name of responsible person
Sarvar Alipour
Street address
Research Division, 3rd Floor, Central Building No.2, Golgasht Ave. Azadi st.
City
Tabriz
Grant name
Grant code / Reference number
no
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University Of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University Of Medical Science
Full name of responsible person
Arezoo Mehrara
Position
Resident of Psychology
Other areas of specialty/work
Street address
4th Floor, Block F, Atebba Building, Noor st, Yaghchian
City
Tabriz
Postal code
00000000
Phone
+98 41 3386 4208
Fax
+98 00000
Email
arezoo.mehrara@gmail.com
Web page address
Not present

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University Of Medical Science
Full name of responsible person
Arezoo Mehrara
Position
Resident of Psychology
Other areas of specialty/work
Street address
4th Floor, Block F, Atebba Building, Noor st. Yaghchian
City
Tabriz
Postal code
0000000000
Phone
+98 41 3386 4208
Fax
+98 000000
Email
arezoo.mehrara@gmail.com
Web page address
Not present

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University Of Medical Science
Full name of responsible person
Alireza Farnam
Position
Psychologist
Other areas of specialty/work
Street address
Razi Hospital, El Goli road, Tabriz
City
Tabriz
Postal code
00000000
Phone
+98 0000
Fax
+98 00000
Email
alirezafarnam@yahoo.com
Web page address
Not present

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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