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

NCT00361062 | Completed

• 1 other identifier: hae064910706ctil
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Adverse Effects; Aggression

Keywords

aggressive; SSRI's; simulation; behavioral; Side Effects, Psychological; adverse effects; Serotonin Reuptake Inhibitors; aggressive behavior; computer simulation

Outcome Measures

Primary Outcomes (1)

• aggressiveness level

  whithin 1 month

Interventions

comparative computer simulation BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18 years
• Instructed by his/her family physician to start taking a medicine in the SSRI group

You may not qualify if:

• 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

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (2)

HaEmek Medical Center

Afula, Ysrael Valley, 18101, Israel

Location

HaEmek Medical Center

Afula, Israel

Location

MeSH Terms

Conditions

Aggression; Behavior

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Social Behavior

Study Officials

• Dalya Navot-Mintzer, MD

  HaEmek Medical Center, Family Practice Ward

  PRINCIPAL INVESTIGATOR

• Dalya Navot-Mintzer, MD

  HaEmek Medical Center, Family Practice Ward

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 4, 2006
• First Posted: August 7, 2006
• Study Start: September 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: March 1, 2012
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

IL (2)