Serotonin and Everyday Social Interaction

NCT02051569 | Completed Early Phase 1

• 1 other identifier: NL451-09-013 / 2
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Social Behaviour

Outcome Measures

Primary Outcomes (1)

• quarrelsome behaviour

  quarrelsome behaviour is measured daily for 28 days using Ecological Momentary Assessment.

  28 days

Secondary Outcomes (4)

• interpersonal behaviour

  28 days

• affect

  28 days

• perceptions of others

  28 days

• social cognitions

  28 days

Other Outcomes (1)

• Serotonin transporter polymorphism

  1 day

Study Arms (2)

Tryptophan first

EXPERIMENTAL

Tryptophan is given for the first 14 days, 6 times 500mg per day. Placebo is given 6 times per day for the second 14 days.

Dietary Supplement: Tryptophan

Tryptophan second

EXPERIMENTAL

Placebo is given 6 times per day for the first 14 days. Tryptophan is given for the second 14 days, 6 times 500mg per day.

Dietary Supplement: Tryptophan

Interventions

Tryptophan DIETARY_SUPPLEMENT

Tryptophan and placebo are given in a crossover design, based on randomisation.

Tryptophan first; Tryptophan second

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years
• At least one first-degree family member with MDD
• Willingness to cooperate; to sign written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Groningen: lead

MeSH Terms

Conditions

Social Behavior

Interventions

Tryptophan

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Marije aan het Rot, Dr.

  University of Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: January 31, 2014
• Study Start: August 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 31, 2014

Record last verified: 2014-01