MoodEarly Phase 1NCT02051530
Mood, Serotonin and Social Interaction
A Early Phase 1 study testing tryptophan depletion in people with Mood and Social Behavior, run by University of Groningen at 1 site in Netherlands.
Trial summary
Rationale: 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood, Social Behavior
- What is being tested?
- tryptophan depletion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2012to Mar 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 to 65 yrs
- At least one first-degree family member with MDD, Family History (FH) positive, or no first and -second degree family members with MDD, FH negative
- Willingness to cooperate, to sign written informed consent
Who cannot join
- Any current or past Diagnostic and Statistical Manual (DSM) IV Axis I mood disorder, anxiety disorder, psychotic disorder, eating disorder, or somatoform disorder as determined by Structured Clinical Interview for DSM interview
- Any current substance use disorder
- Any past substance dependence
- Ongoing medical treatment for a chronic disease, particularly cancer, gastrointestinal disease, phenylketonuria, 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Center Psychiatry
Groningen, Provincie Groningen, 9713 GZ
About this study
Rationale: 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.
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.
Read the detailed description
see summary
- Conditions
- Mood, Social Behavior
- Being tested
- tryptophan depletion
- Keywords
- mood, empathy, mimicry, emotional reactivity, prosody
- Medical subject headings
- Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tryptophan depletionDietary supplement
tryptophan depletion involves the ingestion of an amino acid mixture that is devoid of tryptophan. on the other day participants receive placebo, being the same mixture but including tryptophan
| Study group | Role | What they receive |
|---|---|---|
| tryptophan depletion first day | Experimental | tryptophan depletion on the first day. on the other day participants receive placebo. Receives: Dietary Supplement: tryptophan depletion |
| tryptophan depletion on day 2 | Experimental | tryptophan depletion on the second day. on the first day participants receive placebo. Receives: Dietary Supplement: tryptophan depletion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Empathic Accuracy
Empathic Accuracy is assessed with a computer task, approximately 6 hrs after completion of the amino acid mixture
Measured: 45 minutes
Secondary outcomes (4)
Behavioral mimicry
Behavioral mimicry is assessed in two experiments. In the first experiment, mimicry of a person in a video is assessed. In a second experiment mimicry is assessed in response to the investigators mannerisms
Measured: 10 minutes
Emotional Prosody (EP)
EP is assessed in two experiments. In the first experiment, EP is assessed in response to a video. In a second experiment EP is assessed in a dyad with the investigator.
Measured: 10 minutes
blood
blood is analysed for levels of tryptophan, oxytocin and cortisol
Measured: 10 minutes
heart rate variability
hrv is measured in response to emotional video clips
Measured: 1 hour
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 startApr 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MoodStudies 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
- NCT02051530
- Sponsor's protocol ID
- NL451-09-013
- Status last verified
- Jan 2015
- First submitted
- 24 Jan 2014
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hogenelst K, Schoevers RA, Kema IP, Sweep FC, aan het Rot M. Empathic accuracy and oxytocin after tryptophan depletion in adults at risk for depression. Psychopharmacology (Berl). 2016 Jan;233(1):111-20. doi: 10.1007/s00213-015-4093-9.
PubMed 26462806
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mood, Serotonin and Social Interaction
- ClinicalTrials.gov ID
- NCT02051530
- Acronym / sponsor ID
- NL451-09-013
- Conditions
- Mood, Social Behavior
- Keywords
- mood, empathy, mimicry, emotional reactivity, prosody
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of GroningenUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 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: 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.
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.
Detailed description
see summary
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tryptophan depletion first day | Experimental | Dietary Supplement: tryptophan depletiontryptophan depletion on the first day. on the other day participants receive placebo. |
| tryptophan depletion on day 2 | Experimental | Dietary Supplement: tryptophan depletiontryptophan depletion on the second day. on the first day participants receive placebo. |
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 to 65 yrs
- At least one first-degree family member with MDD, Family History (FH) positive, or no first and -second degree family members with MDD, FH negative
- Willingness to cooperate, to sign written informed consent
Key exclusion criteria (8 listed)
- Any current or past Diagnostic and Statistical Manual (DSM) IV Axis I mood disorder, anxiety disorder, psychotic disorder, eating disorder, or somatoform disorder as determined by Structured Clinical Interview for DSM interview
- Any current substance use disorder
- Any past substance dependence
- Ongoing medical treatment for a chronic disease, particularly cancer, gastrointestinal disease, phenylketonuria, diabetes, cardiovascular disease, or disease of the liver or kidneys
- 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 |
|---|---|---|
| tryptophan depletiontryptophan depletion involves the ingestion of an amino acid mixture that is devoid of tryptophan. on the other day participants receive placebo, being the same mixture but including tryptophan | Dietary supplement | tryptophan depletion first day, tryptophan depletion on day 2 |
Primary outcome
Empathic Accuracy
Time frame: 45 minutes
Empathic Accuracy is assessed with a computer task, approximately 6 hrs after completion of the amino acid mixture
4 secondary outcomes
Behavioral mimicry
Time frame: 10 minutes
Emotional Prosody (EP)
Time frame: 10 minutes
blood
Time frame: 10 minutes
heart rate variability
Time frame: 1 hour
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 30 Jan 2015.
- Derived from this study: PubMed 26462806Hogenelst K, Schoevers RA, Kema IP, Sweep FC, aan het Rot M. Empathic accuracy and oxytocin after tryptophan depletion in adults at risk for depression. Psychopharmacology (Berl). 2016 Jan;233(1):111-20. doi: 10.1007/s00213-015-4093-9.
Related trials for Mood
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
RecruitingPhase 2
A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
Major Depressive Episode (MDE), Major Depressive Disorder (MDD)
RecruitingPhase 1
Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
Depression, Major Depressive Disorder
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing tryptophan depletion in people with Mood and Social Behavior, run by University of Groningen at 1 site in Netherlands.
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 8 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 30 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Empathic Accuracy (time frame: 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02051530, which also lists 1 linked publication.
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 30 Jan 2015.