The primary research question of this study is:*What is the effect of omega-3 fatty acids dietary supplementation compared to placebo in the treatment of impulsivity in patients with a personality disorder?*The secondary research question of this…
ID
Source
Brief title
Condition
- Other condition
- Personality disorders and disturbances in behaviour
Synonym
Health condition
impulsiviteit
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is impulsivity, which will be measured by
self-report questionnaires and computerized cognitive tasks.
Secondary outcome
The secondary study parameters are several psychological symptoms, among which
depression. These complaints will be measured by a self-report questionnaire
and a semi-standardized interview-observation scale.
Background summary
Omega-3 fatty acids (DHA and EPA), generally known as fish oil, has proven to
be important for physical health. Since years, researchers study the
contribution of fish oil to mental health and the treatment of several
psychological symptoms or psychiatric disorders. Research findings show that
fish oil can be of therapeutic value for several psychological complaints.
The aim of this study is to examine the effect of omega-3 fatty acids on
impulsivity in patients with a personality disorder. Impulsivity is a common
problem within this group of patients and the opportunities for treatment are
still limited.
Some research findings show positive effects in reducing impulsivity by omega-3
fatty acids. In this study, it will be examined if these results can be replied
in a Dutch group of people with personality disorders, being in outpatient
treatment.
If omega-3 fatty acids prove to have a positive effect in the reduction of
impulsivity, it would implicate an extra treatment opportunity for people with
impulsivity problems.
The hypothesis is that omega-3 fatty acids dietary supplementation compared to
placebo has a significant beneficial effect on impulsivity in patients with a
personality order.
Study objective
The primary research question of this study is:
*What is the effect of omega-3 fatty acids dietary supplementation compared to
placebo in the treatment of impulsivity in patients with a personality
disorder?*
The secondary research question of this study is:
*What is the effect of omega-3 fatty acids dietary supplementation compared to
placebo on other psychological complaints, like depression, anxiety and
hostility?*
Study design
A double- blind, randomized, placebo-controlled trial.
Intervention
Subjects are prescribed to take in fish oil - or placebo capsules (randomly
assigned and double blind) for 8 weeks on a daily basis.
Impulsivity (and other psychological symptoms) will be measured at intake,
after 1 week and then again after 7 weeks.
Before and after the 8 weeks of study a blood sample will be taken to control
for compliance and for a possible increased fish or fish oil consumption in the
placebo group.
Study burden and risks
The burden for subjects can be described as follows. Blood samples will be
taken 2 times, daily intake of 4g fish oil- or placebo capsules, administration
of an interview, self-report questionnaires and computerized tasks. Total
duration: 4-4,5 hours. The subject have to travel 3 times to the laboratory of
PsyQ.
All the interventions are spread over 8 weeks, which diminishes the burden for
the subjects. The clear and full explanation of the study before participation,
the possibility to contact the independent physician and the possibility to
stop participating in the study at any time, are factors which can diminisch
the burden for the subjects.
The risks of participation in this study are minimal. The side effects of 4
gram of fish oil per day are rare and minimal.
Wassenaarseweg 52
2333 AK Leiden
Nederland
Wassenaarseweg 52
2333 AK Leiden
Nederland
Listed location countries
Age
Inclusion criteria
- Dutch speaking men and women
- Presence of a cluster B personality disorder or a Personality disorder Not Otherwise Specified (according to the DSM-IV)
- Presence of impulsivity (according to the DSM-IV diagnostic criteria for impulsivity in the Axis II Personality disorders and according to the Barratt Impulsiveness Scale BIS-11)
Exclusion criteria
- Current substance abuse or dependence (DSM-IV criteria)
- Current use of medication, unless the intake is stable
- Current use of omega-3 fatty acids dietary supplements or eating more than 1 fatty fish per week
- Diagnosis of a psychotic disorder, bipolar disorder or a major depressive episode (DSM-IV criteria)
- Patients, participating in the module for Impulscontrol (CPP) during the 8 weeks of the study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL17466.097.07 |