Adverse EffectsNCT00361062
Aggressive Behavior Induced by Selective Serotonin Reuptake Inhibitors (SSRIs) During the First Month of Treatment
A study testing comparative computer simulation in people with Adverse Effects and Aggression, run by HaEmek Medical Center, Israel at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adverse Effects, Aggression
- What is being tested?
- comparative computer simulation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 2 sitesIsrael
- Study dates
- Sep 2006to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age above 18 years
- Instructed by his/her family physician to start taking a medicine in the SSRI group
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
HaEmek Medical Center
Afula, Ysrael Valley, 18101
HaEmek Medical Center
Afula
About this study
Official title: Aggressive Behavior Induced by SSRIs During the First Month of Treatment
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.
Read the 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
- Being tested
- comparative computer simulation
- Keywords
- aggressive, SSRI's, simulation, behavioral, Side Effects, Psychological, adverse effects, Serotonin Reuptake Inhibitors, aggressive behavior, computer simulation
- Medical subject headings
- Aggression, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparative computer simulationBehavioural
comparative computer simulation assessing the level of aggressiveness before and after the beginning of SSRI treatment.
What is being measured
The primary outcome is the main question the study is designed to answer.
aggressiveness level
Measured: whithin 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionJul 2008
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse EffectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Investigators
- Dalya Navot-Mintzer, MD, Principal investigator, HaEmek Medical Center, Family Practice WardDalya Navot-Mintzer, MD, Study director, HaEmek Medical Center, Family Practice Ward
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361062
- Sponsor's protocol ID
- hae064910706ctil
- Status last verified
- Feb 2020
- First submitted
- 4 Aug 2006
- Last updated
- 13 Feb 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aggressive Behavior Induced by SSRIs During the First Month of Treatment
- ClinicalTrials.gov ID
- NCT00361062
- Acronym / sponsor ID
- hae064910706ctil
- Conditions
- Adverse Effects, Aggression
- Keywords
- aggressive, SSRI's, simulation, behavioral, Side Effects, Psychological, adverse effects, Serotonin Reuptake Inhibitors, aggressive behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Sep 2006 (actual)
- Primary completion
- Jul 2008 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 7 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age above 18 years
- Instructed by his/her family physician to start taking a medicine in the SSRI group
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comparative computer simulationcomparative computer simulation assessing the level of aggressiveness before and after the beginning of SSRI treatment. | Behavioural | – |
Primary outcome
aggressiveness level
Time frame: whithin 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalya Navot-Mintzer, MD principal investigator
HaEmek Medical Center, Family Practice Ward
Dalya Navot-Mintzer, MD study director
HaEmek Medical Center, Family Practice Ward
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comparative computer simulation in people with Adverse Effects and Aggression, run by HaEmek Medical Center, Israel at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
aggressiveness level (time frame: whithin 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.