Aggressive Behavior Induced by Selective Serotonin Reuptake Inhibitors (SSRIs) During the First Month of Treatment
Primary Purpose
Adverse Effects, Aggression
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
comparative computer simulation
Sponsored by
About this trial
This is an interventional other trial for Adverse Effects focused on measuring aggressive, SSRI's, simulation, behavioral, Side Effects, Psychological, adverse effects, Serotonin Reuptake Inhibitors, aggressive behavior, computer simulation
Eligibility Criteria
Inclusion Criteria: Age above 18 years Instructed by his/her family physician to start taking a medicine in the SSRI group Exclusion Criteria: According to the family practitioner's record: under SSRI, SNRI, or NRI treatment during the previous 3 months or at the time of entry into the study. Diagnosed with schizophrenia or active psychosis or impaired judgment Anti-social personality disorder Drug use or alcohol abuse
Sites / Locations
- HaEmek Medical Center
- HaEmek Medical Center
Outcomes
Primary Outcome Measures
aggressiveness level
Secondary Outcome Measures
Full Information
NCT ID
NCT00361062
First Posted
August 4, 2006
Last Updated
February 11, 2020
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT00361062
Brief Title
Aggressive Behavior Induced by Selective Serotonin Reuptake Inhibitors (SSRIs) During the First Month of Treatment
Official Title
Aggressive Behavior Induced by SSRIs During the First Month of Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 2006 (Actual)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
5. Study Description
Brief Summary
SSRIs are the first line of therapy for anxiety and depressive disorders and for many other clinical diagnoses. One of the most disturbing side effects that is observed is a tendency towards aggressiveness among patients receiving medications from this group, mainly during the first month of therapy. Aggressive behavior tends to occur in some individuals but not in others. In some sub-groups of people, personality and character traits might make a person more prone to aggressive behavior.
In this study the investigators try to estimate the tendency towards aggressive behavior in patients prescribed to a medication from the SSRI group. By using a comparative computer simulation they hope to be able to detect delicate changes and to maybe get some clues of the personalities prone to aggressive behavior in the future.
Detailed Description
Selective serotonin reuptake inhibitors (SSRIs) became the first line therapy for anxiety and depressive disorders and for many other clinical diagnoses. One of the most disturbing side effects that is observed is a tendency towards aggressiveness among patients receiving medications from this group, mainly during the first (one month) period of therapy. Aggressive behavior tends to occur in some individuals but not in others. Until now most of the cases and reports in the literature demonstrate the extreme events of aggressive behavior. These personality or any other character traits that are more prone to develop aggressiveness have not been studied and it is not clear if this side effect manifests itself just in the extreme rare cases or if it is a more common phenomenon that occurs in a wider group of people.
In this study we try to estimate the tendency towards aggressive behavior of patients prescribed to a medication of the SSRI group. By using a comparative computer simulation we hope to be able to detect more delicate changes and maybe to get some clues of the personalities prone to aggressive behavior in the future.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Effects, Aggression
Keywords
aggressive, SSRI's, simulation, behavioral, Side Effects, Psychological, adverse effects, Serotonin Reuptake Inhibitors, aggressive behavior, computer simulation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
comparative computer simulation
Intervention Description
comparative computer simulation assessing the level of aggressiveness before and after the beginning of SSRI treatment.
Primary Outcome Measure Information:
Title
aggressiveness level
Time Frame
whithin 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age above 18 years
Instructed by his/her family physician to start taking a medicine in the SSRI group
Exclusion Criteria:
According to the family practitioner's record: under SSRI, SNRI, or NRI treatment during the previous 3 months or at the time of entry into the study.
Diagnosed with schizophrenia or active psychosis or impaired judgment
Anti-social personality disorder
Drug use or alcohol abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dalya Navot-Mintzer, MD
Organizational Affiliation
HaEmek Medical Center, Family Practice Ward
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dalya Navot-Mintzer, MD
Organizational Affiliation
HaEmek Medical Center, Family Practice Ward
Official's Role
Study Director
Facility Information:
Facility Name
HaEmek Medical Center
City
Afula
State/Province
Ysrael Valley
ZIP/Postal Code
18101
Country
Israel
Facility Name
HaEmek Medical Center
City
Afula
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Aggressive Behavior Induced by Selective Serotonin Reuptake Inhibitors (SSRIs) During the First Month of Treatment
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