This study aims to investigate how serotonin influences social functioning in healthy adults with a first-degree family member diagnosed with MDD. The primary goal is to investigate the effect of an experimental increase in brain serotonin on…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the level of quarrelsome behaviour measured using ecological
momentary assessment.
Secondary outcome
Secondary outcome measures include levels of agreeable, dominant, and
submissive behaviours, as well as affect, cognitions, and perceptions. Finally,
polymorphisms of genes thought to be related to MDD may be determined.
Background summary
Poor social functioning may contribute to major depressive disorder (MDD). Low
serotonin levels may also contribute to MDD. Recent research suggests that
serotonin plays a role in regulating human social behaviour. Therefore it would
be intriguing to investigate the effect of serotonin on the quality of everyday
social interactions in a population at risk for MDD. Human social behaviour can
be reliably assessed in everyday life using Ecological Momentary Assessment
(EMA).
Study objective
This study aims to investigate how serotonin influences social functioning in
healthy adults with a first-degree family member diagnosed with MDD. The
primary goal is to investigate the effect of an experimental increase in brain
serotonin on everyday social behaviour, measured using Ecological Momentary
Assessment. This will be done using oral supplementation with tryptophan, the
amino acid precursor of serotonin. Secondary goals are to determine how this
manipulation influences people*s feelings and thoughts after negative and
positive interpersonal events, as well as their perceptions of other*s social
behaviour. An exploratory goal is to investigate if these effects are moderated
by genes thought to be involved in MDD.
Study design
A mixed design, with gender as between-subjects factor and intervention
(tryptophan or placebo) as within-subjects factor.
Intervention
Participants take 1-gram tryptophan (2 capsules) and identical placebo capsules
three times daily with meals (in total 3 x 2 = 6 capsules per day) for 14 days
each in a randomized, counterbalanced order. The two intervention periods are
separated by 1 week.
Study burden and risks
In general the risks associated with the present study are minimal and the
burden is very low and to the opinion of the investigators justified by the
potential value of the research.
Possible side-effects of tryptophan may be nausea, dizzyness and
lightheadedness.
The burden per participant is estimated to be 12 hours.
Grote Kruisstraat 2/1
Groningen 9712 TS
NL
Grote Kruisstraat 2/1
Groningen 9712 TS
NL
Listed location countries
Age
Inclusion criteria
• Age 18-65 years
• At least one first-degree family member with MDD
• Willingness to cooperate; to sign written informed consent
Exclusion criteria
• Any current or past MDD or other mood disorder as determined by the SCID-NP
• Any current anxiety disorder, psychotic disorder, substance use disorder, eating disorder, or somatoform disorder as determined by SCID-NP
• Any contraindication for the use of tryptophan, i.e. pregnancy, diabetes, cancer or a history of cancer, a history of any scleroderma-like condition, evidence of achlorhydria, upper bowel malabsorption, or irritation of the urinary bladder
• Current use of psychotropic medications including medications for psychiatric problems (e.g., antidepressants such as MAO inhibitors and fluoxetine) or migraines
• Not speaking Dutch fluently
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 | NL38398.042.11 |