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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by HaEmek Medical Center, Israel.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00361062
First received: August 4, 2006
Last updated: June 3, 2010
Last verified: June 2010
  Purpose

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 Intervention
Adverse Effects
Aggression
Behavioral: comparative computer simulation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Aggressive Behavior Induced by SSRIs During the First Month of Treatment

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • aggressiveness level [ Time Frame: whithin 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2006
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: comparative computer simulation
    comparative computer simulation assessing the level of aggressiveness before and after the beginning of SSRI treatment.
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361062

Contacts
Contact: Dalya Navot-Mintzer, MD 00972527950035 ndalya@gmail.com

Locations
Israel
HaEmek Medical Center Not yet recruiting
Afula, Ysrael Valley, Israel, 18101
Contact: Dalya Navot-Mintzer, MD    00972527950035    ndalya@gmail.com   
Principal Investigator: Dalya Navot-Mintzer, MD         
HaEmek Medical Center Recruiting
Afula, Israel
Contact: Dalya Navot-Mintzer    0097246494177    dalya_na@clalit.org.il   
Sponsors and Collaborators
HaEmek Medical Center, Israel
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
  More Information

No publications provided

Responsible Party: Dalya Navot-MIntzer, HaEmek Medical Center
ClinicalTrials.gov Identifier: NCT00361062     History of Changes
Other Study ID Numbers: hae064910706ctil
Study First Received: August 4, 2006
Last Updated: June 3, 2010
Health Authority: Israel: Ethics Commission

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:
Aggression
Behavioral Symptoms
Serotonin Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents

ClinicalTrials.gov processed this record on November 25, 2014