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

NCT ID: NCT00361062

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2012-03-31

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.

Conditions

Adverse Effects; Aggression

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

comparative computer simulation

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HaEmek Medical Center, Israel

OTHER

Sponsor Role: lead

Responsible Party

HaEmek Medical Center

Principal Investigators

Dalya Navot-Mintzer, MD

Role: PRINCIPAL_INVESTIGATOR

HaEmek Medical Center, Family Practice Ward

Dalya Navot-Mintzer, MD

Role: STUDY_DIRECTOR

HaEmek Medical Center, Family Practice Ward

Locations

HaEmek Medical Center

Afula, Ysrael Valley, Israel

HaEmek Medical Center

Afula, , Israel

Countries

Israel

Other Identifiers

hae064910706ctil

Identifier Type: -

Identifier Source: org_study_id