Serotonin and Everyday Social Interaction

Social Behaviour Clinical Trial

Official title:

Everyday Social Behavior and Mood in Individuals With a Family History of Depression. Investigating the Role of Serotonin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02051569
• Other study ID #: NL451-09-013 / 2
• Status: Completed
• Phase: Phase 0
• First received: January 24, 2014
• Last updated: January 29, 2014
• Start date: August 2012
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: University of Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

Rationale: Poor social functioning may contribute to major depressive disorder (MDD). Poor serotonin function 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 role of serotonin in regulating 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).

Objective: This study aims to investigate how an experimental increase in serotonin influences social functioning in healthy adults with a first-degree family member diagnosed with MDD. The primary goal is to investigate the role of serotonin in regulating everyday social behaviour, measured using EMA. This will be done using oral supplementation with tryptophan, the amino acid precursor of serotonin. Secondary goals are to determine how this experimental manipulation influences people's feelings as well as their perceptions of other's social behaviour following interpersonal events, and social cognitions at the end of the day. An exploratory goal is to investigate if these effects are moderated by genes thought to be involved in MDD.

The primary hypothesis to be tested is that tryptophan will reduce quarrelsome behaviour.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID)

• Any current anxiety disorder, psychotic disorder, substance use disorder, eating disorder, or somatoform disorder as determined by SCID

• 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 Mono Amine Oxidase inhibitors and fluoxetine) or migraines

• Not speaking Dutch fluently

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Social Behaviour

Intervention

Dietary Supplement:
• Tryptophan
Tryptophan and placebo are given in a crossover design, based on randomisation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Groningen

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serotonin transporter polymorphism	Prior to starting the 28 days of social interacton recording participants are instructed about the study procedures. The saliva samples are analyzed for Serotonin transporter polymorphism.	1 day	No
Primary	quarrelsome behaviour	quarrelsome behaviour is measured daily for 28 days using Ecological Momentary Assessment.	28 days	No
Secondary	interpersonal behaviour	measures are assessed on a daily basis for 28 days with ecological momentary assessment	28 days	No
Secondary	affect	measures are assessed on a daily basis for 28 days with ecological momentary assessment	28 days	No
Secondary	perceptions of others	measures are assessed on a daily basis for 28 days with ecological momentary assessment	28 days	No
Secondary	social cognitions	measures are assessed daily for 28 days with ecological momentary assessment	28 days	No