This project aims to study how changes in serotonin alter interpersonal functioning in adults with or without a first degree family member diagnosed with MDD. The primary goal is to investigate the effect of experimentally lowered brain serotonin…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is empathic accuracy measured with an empathic accuracy task
(EAT).
Secondary outcome
Secondary outcome measures are the amount of behavioural mimicry, speech
characteristics, heart rate variability (HRV), scores on the Positive and
Negative Affect Schedule (PANAS) and Visual Analogue Scale (VAS). Finally,
polymorphisms of genes thought to be related to MDD are analysed.
Background summary
Major depressive disorder (MDD) is a psychiatric disorder whose onset,
severity, and duration are influenced by interpersonal factors. The serotonin
system is known to influence MDD risk. Recent research has suggested that
serotonin may also play a role in regulating social behaviour. Therefore, it
would be interesting to study the role of serotonin in responses to social
stimuli in individuals at risk for MDD.
Study objective
This project aims to study how changes in serotonin alter interpersonal
functioning in adults with or without a first degree family member diagnosed
with MDD. The primary goal is to investigate the effect of experimentally
lowered brain serotonin levels on empathic accuracy. Secondary goals are to
determine how this manipulation influences verbal and non-verbal communication,
cardiovascular function in a social context, and mood. An exploratory goal is
to investigate how these outcomes are related to genes thought to be involved
in MDD.
Study design
A mixed design, with family history (FH+ and FH-) as between-subjects factor
and intervention (ATD or placebo) as within-subjects factor.
Intervention
Participants receive, in a randomized, counterbalanced order, and under
double-bind conditions, tryptophan-deficient and balanced amino acid mixtures
on the mornings of two non-consecutive test days.
Study burden and risks
There is no direct benefit to the participants. Participants are not allowed to
eat on test days from 00:00 until 17:00. The greatest potential risk to the
participants involves the possibility of transient occurrence of mild lowering
of mood, especially in those with a family history of depression. In the past
this effect on mood has always been mild and transient and did not require
treatment. Previous studies have shown that mood returns to baseline levels
within 24 hours. Side effects such as nausea or vomiting have also been
observed in previous studies, and may occur in the present study. In addition,
participants may develop bruising from the needle sticks performed to obtain
blood for plasma tryptophan analyses.
Grote Kruisstraat 2/1
9700 AB
NL
Grote Kruisstraat 2/1
9700 AB
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria: Age 18-65 years. At least one first-degree family member with MDD (FH+) or no first- and second-degree family members with MDD (FH-). Willingness to cooperate; to sign written informed consent.
Exclusion criteria
Exclusion criteria: Any current or past DSM-IV Axis I mood disorder, anxiety disorder, psychotic disorder, eating disorder, or somatoform disorder as determined by SCID-NP interview. Any current substance use disorder. Any past substance dependence. Ongoing medical treatment for a chronic disease, particularly cancer, gastrointestinal disease, phenylketonurea, diabetes, cardiovascular disease, or disease of the liver or kidneys. Not speaking Dutch fluently. Current or past use of neuroleptics, sedative drugs, antidepressants etc. On test days, a positive urine test for drugs of abuse. For women, initiation of hormonal contraceptive treatments <= 3 months prior to screening, or a positive urine test for pregnancy on test days
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL34731.042.10 |
| OMON | NL-OMON20623 |