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

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

Tracking Information

• First Submitted Date: August 4, 2006
• First Posted Date: August 7, 2006
• Last Update Posted Date: February 13, 2020
• Actual Study Start Date: September 2006
• Actual Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 30, 2010): aggressiveness level [ Time Frame: whithin 1 month ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other

Condition

• Adverse Effects
• Aggression

Intervention

Behavioral: comparative computer simulation

comparative computer simulation assessing the level of aggressiveness before and after the beginning of SSRI treatment.

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 4, 2006): 60
• Original Enrollment: Same as current
• Actual Study Completion Date: March 2012
• Actual Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT00361062
• Other Study ID Numbers: hae064910706ctil
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Dalya Navot-MIntzer, HaEmek Medical Center
• Original Responsible Party: Not Provided
• Current Study Sponsor: HaEmek Medical Center, Israel
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Dalya Navot-Mintzer, MD; HaEmek Medical Center, Family Practice Ward
• Study Director: Dalya Navot-Mintzer, MD; HaEmek Medical Center, Family Practice Ward

• PRS Account: HaEmek Medical Center, Israel
• Verification Date: February 2020