Clinical trial NCT00361062: 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
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Effects
Aggression
Keywords: aggressive
SSRI's
simulation
behavioral
Side Effects, Psychological
adverse effects
Serotonin Reuptake Inhibitors
aggressive behavior
computer simulation
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2006-08-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: aggressiveness level
timeFrame: whithin 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek Medical Center
state: Ysrael Valley
city: Afula
country: Israel
facility: HaEmek Medical Center
Study officials:
affiliation: HaEmek Medical Center, Family Practice Ward
name: Dalya Navot-Mintzer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HaEmek Medical Center, Family Practice Ward
name: Dalya Navot-Mintzer, MD
role: STUDY_DIRECTOR
References: