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Aggressive Behavior Induced by Selective Serotonin Reuptake Inhibitors (SSRIs) During the First Month of Treatment

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ClinicalTrials.gov Identifier: NCT00361062
Recruitment Status : Completed
First Posted : August 7, 2006
Last Update Posted : February 13, 2020
Sponsor:
Information provided by:
HaEmek Medical Center, Israel

Study Description
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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.


Condition or disease Intervention/treatment Phase
Adverse Effects Aggression Behavioral: comparative computer simulation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Aggressive Behavior Induced by SSRIs During the First Month of Treatment
Actual Study Start Date : September 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : March 2012
Arms and Interventions
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Intervention Details:
  • Behavioral: comparative computer simulation
    comparative computer simulation assessing the level of aggressiveness before and after the beginning of SSRI treatment.

Outcome Measures
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Primary Outcome Measures :
  1. aggressiveness level [ Time Frame: whithin 1 month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00361062


Locations
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Israel
HaEmek Medical Center
Afula, Ysrael Valley, Israel, 18101
HaEmek Medical Center
Afula, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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Principal Investigator: Dalya Navot-Mintzer, MD HaEmek Medical Center, Family Practice Ward
Study Director: Dalya Navot-Mintzer, MD HaEmek Medical Center, Family Practice Ward
More Information
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Responsible Party: Dalya Navot-MIntzer, HaEmek Medical Center
ClinicalTrials.gov Identifier: NCT00361062    
Other Study ID Numbers: hae064910706ctil
First Posted: August 7, 2006    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Keywords provided by HaEmek Medical Center, Israel:
aggressive
SSRI's
simulation
behavioral
Side Effects, Psychological
 adverse effects
Serotonin Reuptake Inhibitors
aggressive behavior
computer simulation
Additional relevant MeSH terms:
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Aggression
Aberrant Motor Behavior in Dementia
Behavioral Symptoms