Replication of the study of Amminger et al (2010) in a larger sample.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
symptomatische patiënten met een verhoogd risico op een eerste psychose
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Transition to psychosis
Secondary outcome
Severity of symptoms
Level of functioning
Background summary
A recent study of Amminger et al published in the Archives of General
Psychiatry showed that in a group of 81 patients with an ultra high risk for
developing a first psychosis, the risk of making the transition to psychosis
was reduced significantly in the patient group treated with fishoil compared to
the patient group treated with a placebo. Since antipsychotic medication is not
indicated in the ultra high risk phase because of side-effects, it would be
highly relevant to replicate this finding. If this replication study also
reveals that fishoil can reduce the chance of transition to a first psychosis,
this result could have implications for the treatment of subjects wit a high
risk for developing psychosis.
Study objective
Replication of the study of Amminger et al (2010) in a larger sample.
Study design
337 patients with an ultra high risk for developing psychosis will be
randomised into treatment condition (fishoil and cognitive behavioural therapy
plus case management) and placebo condition (placebo and cognitive behavioral
management plus case management). Treatment duration is six months and total
study duration is one year.
Intervention
Condition 1: fishoil and cognitive behavioural therapy plus casemanagement
Condition 2: placebo and cognitive behavioural therapy plus casemanagement
Study burden and risks
Few risks are involved (only when taking blood samples and fishoil may lead to
mild gastro-intestinal problems or burping) and there are obvious benefits for
the patients because they receive treatment for their symptoms and the risk for
transition to a first psychosis may be reduced. In the first 6 months, patients
will be interviewed monthly to rate the severity of symptoms. These interview
appointments can be combined with treatment appointments. Thereafter, subjects
will be interviewed at 9, 12 and 24 months. Total research burden is estimated
at 27,5 hours.
Popular Road 35
Victoria 3052
AU
Popular Road 35
Victoria 3052
AU
Listed location countries
Age
Inclusion criteria
A. General inclusion criteria:
i. Ability to give informed consent
Where participants are of legal childhood age, consent will also be obtained from one
of the participant*s parents. Both the parent and participant will be required to sign
the consent form in such a case. It will be the investigator*s responsibility to determine
whether a participant of legal childhood age has the capacity to consent to the study.
ii. Age 13 - 40 yrs
B. Membership of one of the following *at-risk* groups:
i. Vulnerability (Trait and State Risk Factor) Group: Individuals with a combination of a
trait risk factor (schizotypal personality disorder or a family history of psychotic disorder in
a first degree relative) and a significant deterioration in mental state and/or functioning or
sustained low functioning during the past year.
ii. Attenuated Psychotic Symptoms (APS) Group: Individuals with subthreshold (intensity
or frequency) positive psychotic symptoms. The symptoms must have been present during
the past year and be associated with a significant reduction in or sustained low functioning.
iii. Brief Limited Intermittent Psychotic Symptoms Group (BLIPS): Individuals with a
recent history of frank psychotic symptoms that resolved spontaneously (without
antipsychotic medication) within one week. The symptoms must have been present during
the past year and be associated with a significant reduction in or sustained low functioning.
Exclusion criteria
i. Past history of a treated or untreated psychotic episode of one week*s duration or
longer
ii. Organic brain disease, e.g. epilepsy, inflammatory brain disease
iii. Abnormal coagulation profile parameters or thyroid function test results >10% above
or below the limits of the normal range.
iv. Any physical illness with psychotropic effect, if not stabilized
v. Current treatment with lithium, methyl phenidate or ketamine, or recreational use of
ketamine.
vi. Past neuroleptic exposure equivalent to a total lifetime haloperidol dose of >50 mg.
[Refer to Appendix IV for a list of equivalent doses for other neuroleptic agents.]
vii. Diagnosis of a serious developmental disorder, e.g. Asperger's syndrome
viii. Premorbid IQ < 70 and a documented history of developmental delay or intellectual
disability
ix. Current aggression/dangerous behaviour (CAARMS 5.4 severity score 6)
x. Current suicidality/self harm (CAARMS 7.3 severity score 6)
xi. Current pregnancy
xii. Current attenuated symptoms that are entirely explained by acute intoxication (e.g.,
current attenuated symptoms entirely explained by LSD use).
xiii. > than 4 weeks of regular omega-3 supplementation (>2 capsules standard strength
providing >600 mg combined EPA/DHA) within the last 6 months.
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 | NL35421.018.11 |