Social BehaviourEarly Phase 1NCT02051569
Serotonin and Everyday Social Interaction
A Early Phase 1 study testing Tryptophan in people with Social Behaviour, run by University of Groningen.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Behaviour
- What is being tested?
- Tryptophan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Jan 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- At least one first-degree family member with MDD
- Willingness to cooperate; to sign written informed consent
Who cannot join
- 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
About this study
Official title: Everyday Social Behavior and Mood in Individuals With a Family History of Depression. Investigating the Role of Serotonin
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
- Being tested
- Tryptophan
- Medical subject headings
- Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TryptophanDietary supplement
Tryptophan and placebo are given in a crossover design, based on randomisation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Tryptophan |
What is being measured
The primary outcome is the main question the study is designed to answer.
quarrelsome behaviour
quarrelsome behaviour is measured daily for 28 days using Ecological Momentary Assessment.
Measured: 28 days
Secondary outcomes (4)
interpersonal behaviour
measures are assessed on a daily basis for 28 days with ecological momentary assessment
Measured: 28 days
affect
measures are assessed on a daily basis for 28 days with ecological momentary assessment
Measured: 28 days
perceptions of others
measures are assessed on a daily basis for 28 days with ecological momentary assessment
Measured: 28 days
social cognitions
measures are assessed daily for 28 days with ecological momentary assessment
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startAug 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social BehaviourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marije aan het Rot, University of Groningen
- Investigators
- Marije aan het Rot, Dr., Principal investigator, University of Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051569
- Sponsor's protocol ID
- NL451-09-013 / 2
- Status last verified
- Jan 2014
- First submitted
- 24 Jan 2014
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Everyday Social Behavior and Mood in Individuals With a Family History of Depression. Investigating the Role of Serotonin
- ClinicalTrials.gov ID
- NCT02051569
- Acronym / sponsor ID
- NL451-09-013 / 2
- Conditions
- Social Behaviour
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of GroningenUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 31 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tryptophan first | Experimental | Dietary Supplement: TryptophanTryptophan is given for the first 14 days, 6 times 500mg per day. Placebo is given 6 times per day for the second 14 days. |
| Tryptophan second | Experimental | Dietary Supplement: TryptophanPlacebo is given 6 times per day for the first 14 days. Tryptophan is given for the second 14 days, 6 times 500mg per day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years
- At least one first-degree family member with MDD
- Willingness to cooperate; to sign written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TryptophanTryptophan and placebo are given in a crossover design, based on randomisation. | Dietary supplement | Tryptophan first, Tryptophan second |
Primary outcome
quarrelsome behaviour
Time frame: 28 days
quarrelsome behaviour is measured daily for 28 days using Ecological Momentary Assessment.
4 secondary outcomes
interpersonal behaviour
Time frame: 28 days
affect
Time frame: 28 days
perceptions of others
Time frame: 28 days
social cognitions
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marije aan het Rot, Dr. principal investigator
University of Groningen
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tryptophan in people with Social Behaviour, run by University of Groningen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quarrelsome behaviour (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2014; AzTrials last refreshed its copy on 29 Oct 2026.