MoodNCT01514409
Sub-chronic Effects of 5-hydroxytryptophan on Mood and Emotional Processing in Healthy Volunteers
A study testing 5-Hydroxytryptophan and Pharmaceutical grade silica in people with Mood, run by Northumbria University at 1 site in United Kingdom.
Trial summary
5-hydroxytryptophan (5-HTP) is a nutritional supplement sold in many health food stores, and is taken in order to raise levels of serotonin in the brain. Serotonin is a neurotransmitter that is involved in the regulation of mood. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood
- What is being tested?
- 5-Hydroxytryptophan and Pharmaceutical grade silica
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2011to Aug 2011
- Phase
- Interventional
- 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
- Male/Female
- Healthy
- Aged 18-65
- Not taking any herbal or prescription medications (excluding contraceptive pill)
- Free from depressive illness or mood disorder for the last 6 months
- Free of physical illness
Who cannot join
- Physically ill
- History of medical illness
- Current or previous (6 month) history of psychiatric disorder
- Pregnant/breastfeeding
- Allergy or hypersensitivity to any of the ingredients contained in the investigational product
- Taking any medication (excluding contraceptive pill)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sub-chronic Effects of 5-hydroxytryptophan on Mood and Emotional Processing in Healthy Volunteers: A Randomised Trial
5-hydroxytryptophan (5-HTP) is a nutritional supplement sold in many health food stores, and is taken in order to raise levels of serotonin in the brain. Serotonin is a neurotransmitter that is involved in the regulation of mood.
Previous research has assessed the effects of raising serotonin levels using tryptophan (the precursor of 5-HTP) and serotonergic antidepressants on emotional processing in healthy volunteers. However, to date there has been no human trial investigating the effects of 5-HTP on emotional processing in healthy volunteers.
Thus, the current study aims to assess the effects of 5-HTP, on emotional processing and mood in healthy volunteers.
Read the detailed description
The serotonin precursor 5-HTP is sold as a nutritional supplement and has been used to offset low mood for over 30 years due to its ability to raise levels of neural serotonin. However, evidence for the efficiency of 5-HTP is limited and the mechanism of action of 5-HTP in offsetting low mood has not been well-characterised.
The current study assessed the ability of 5-HTP to induce biases for positive emotional material in healthy volunteers, similar to those induced by serotonergic antidepressants and the nutritional supplement tryptophan. The effects of 5-HTP on subjective mood and depressive symptoms were also assessed.
Participants were randomised to receive either 150mg of 5-HTP or placebo daily for 14 days. Depressive symptoms and subjective mood were assessed pre- and post-intervention. Emotional processing was assessed on the 15th day using a battery of emotionally valenced cognitive tasks.
- Conditions
- Mood
- Being tested
- 5-Hydroxytryptophan, Pharmaceutical grade silica
- Keywords
- 5-hydroxytryptophan, Mood, Emotional Processing, Emotional Cognition, Nutritional Supplement, Low mood
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-HydroxytryptophanDietary supplement
Thirty-three participants were randomly allocated in a double-blind manner to receive either 3x50mg capsules of 5-HTP or placebo (silica) for 14 days.
5-HTP is produced commercially by extraction from the seeds of the African plant griffonia simplicifolia.
Pharmaceutical grade silicaDietary supplement
Pharmaceutical grade silica was utilized as placebo
| Study group | Role | What they receive |
|---|---|---|
| 5-Hydroxytryptophan | Experimental | Not described Receives: Dietary Supplement: 5-Hydroxytryptophan |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Pharmaceutical grade silica |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory-II (BDI-II)
The BDI-II is a measure used to assess the severity of depressive symptoms. It is comprised of 21 items that are scored on a scale ranging from 0-3, with total scores ranging from 0-63. Scores of over 16 are indicative of depressive symptoms.
Measured: 14 days
Profile of Mood States-Bipolar (POMS-BI)
The POMS-BI is a measure used to assess subjective mood. It comprises 72 adjectives which describe mood states. Participants indicate how well the adjectives describe how they feel on a four point scale ranging from 0-3. The POMS-BI measures the following six bipolar mood states: composed-anxious, elated-depressed, agreeable-hostile, clearheaded-confused, energetic-tired, and confident-unsure.
Measured: 14 days
Emotional Perception: Facial Expression Recognition Task
Participants are shown faces displaying five different emotions - happiness, sadness, fear, anger, and disgust. Each facial expression has been morphed between 0% (neutral) to 100% in 25% increments. Four examples of each emotion at each intensity are displayed on a computer screen (84 stimuli presentations in total). Faces are displayed for 500ms aand then replaced with a blank screen. Participants have to indicate what facial expression has been displayed by clicking the corresponding button on-screen with the mouse. Accuracy, reaction times, and misclassifications are measured.
Measured: 14 days
Emotional Categorisation and Memory
Participants are shown sixty personality characteristics consecutively (30 agreeable, 30 disagreeable)on a computer screen in random order for 500ms each. Participants are asked to judge whether the personality traits are 'likeable' or 'dislikeable'. Classifications and reaction times for correct choices are recorded. Participants are then asked to recall as many personality characteristics as they can in order to assess their incidental memory for positive versus negative material.
Measured: 14 days
Emotional Attention: Attentional Probe Task
The attentional probe task based on MacLeod, Matthews and Tata's (1986) visual attention paradigm is used to assess participants attention towards positive versus negatively valenced words. Accuracy and reaction time is recorded.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startMay 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514409
- Sponsor's protocol ID
- 24AQ1
- Status last verified
- Jan 2012
- First submitted
- 17 Jan 2012
- Last updated
- 23 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sub-chronic Effects of 5-hydroxytryptophan on Mood and Emotional Processing in Healthy Volunteers: A Randomised Trial
- ClinicalTrials.gov ID
- NCT01514409
- Acronym / sponsor ID
- 24AQ1
- Conditions
- Mood
- Keywords
- 5-hydroxytryptophan, Mood, Emotional Processing, Emotional Cognition, Nutritional Supplement, Low mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 23 Jan 2012 (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.
5-hydroxytryptophan (5-HTP) is a nutritional supplement sold in many health food stores, and is taken in order to raise levels of serotonin in the brain. Serotonin is a neurotransmitter that is involved in the regulation of mood.
Previous research has assessed the effects of raising serotonin levels using tryptophan (the precursor of 5-HTP) and serotonergic antidepressants on emotional processing in healthy volunteers. However, to date there has been no human trial investigating the effects of 5-HTP on emotional processing in healthy volunteers.
Thus, the current study aims to assess the effects of 5-HTP, on emotional processing and mood in healthy volunteers.
Detailed description
The serotonin precursor 5-HTP is sold as a nutritional supplement and has been used to offset low mood for over 30 years due to its ability to raise levels of neural serotonin. However, evidence for the efficiency of 5-HTP is limited and the mechanism of action of 5-HTP in offsetting low mood has not been well-characterised.
The current study assessed the ability of 5-HTP to induce biases for positive emotional material in healthy volunteers, similar to those induced by serotonergic antidepressants and the nutritional supplement tryptophan. The effects of 5-HTP on subjective mood and depressive symptoms were also assessed.
Participants were randomised to receive either 150mg of 5-HTP or placebo daily for 14 days. Depressive symptoms and subjective mood were assessed pre- and post-intervention. Emotional processing was assessed on the 15th day using a battery of emotionally valenced cognitive tasks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5-Hydroxytryptophan | Experimental | Dietary Supplement: 5-Hydroxytryptophan |
| Placebo | Placebo comparator | Dietary Supplement: Pharmaceutical grade silica |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male/Female
- Healthy
- Aged 18-65
- Not taking any herbal or prescription medications (excluding contraceptive pill)
- Free from depressive illness or mood disorder for the last 6 months
Key exclusion criteria (6 listed)
- Physically ill
- History of medical illness
- Current or previous (6 month) history of psychiatric disorder
- Pregnant/breastfeeding
- Allergy or hypersensitivity to any of the ingredients contained in the investigational product
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 |
|---|---|---|
| 5-HydroxytryptophanThirty-three participants were randomly allocated in a double-blind manner to receive either 3x50mg capsules of 5-HTP or placebo (silica) for 14 days. 5-HTP is produced commercially by extraction from the seeds of the African plant griffonia simplicifolia. | Dietary supplement | 5-Hydroxytryptophan |
| Pharmaceutical grade silicaPharmaceutical grade silica was utilized as placebo | Dietary supplement | Placebo |
Primary outcome
Beck Depression Inventory-II (BDI-II)
Time frame: 14 days
The BDI-II is a measure used to assess the severity of depressive symptoms. It is comprised of 21 items that are scored on a scale ranging from 0-3, with total scores ranging from 0-63. Scores of over 16 are indicative of depressive symptoms.
Profile of Mood States-Bipolar (POMS-BI)
Time frame: 14 days
The POMS-BI is a measure used to assess subjective mood. It comprises 72 adjectives which describe mood states. Participants indicate how well the adjectives describe how they feel on a four point scale ranging from 0-3. The POMS-BI measures the following six bipolar mood states: composed-anxious, elated-depressed, agreeable-hostile, clearheaded-confused, energetic-tired, and confident-unsure.
Emotional Perception: Facial Expression Recognition Task
Time frame: 14 days
Participants are shown faces displaying five different emotions - happiness, sadness, fear, anger, and disgust. Each facial expression has been morphed between 0% (neutral) to 100% in 25% increments. Four examples of each emotion at each intensity are displayed on a computer screen (84 stimuli presentations in total). Faces are displayed for 500ms aand then replaced with a blank screen. Participants have to indicate what facial expression has been displayed by clicking the corresponding button on-screen with the mouse. Accuracy, reaction times, and misclassifications are measured.
Emotional Categorisation and Memory
Time frame: 14 days
Participants are shown sixty personality characteristics consecutively (30 agreeable, 30 disagreeable)on a computer screen in random order for 500ms each. Participants are asked to judge whether the personality traits are 'likeable' or 'dislikeable'. Classifications and reaction times for correct choices are recorded. Participants are then asked to recall as many personality characteristics as they can in order to assess their incidental memory for positive versus negative material.
Emotional Attention: Attentional Probe Task
Time frame: 14 days
The attentional probe task based on MacLeod, Matthews and Tata's (1986) visual attention paradigm is used to assess participants attention towards positive versus negatively valenced words. Accuracy and reaction time is recorded.
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 23 Jan 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-Hydroxytryptophan and Pharmaceutical grade silica in people with Mood, run by Northumbria University at 1 site in United Kingdom.
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 6 inclusion and 6 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 23 Jan 2012. 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 United Kingdom. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Beck Depression Inventory-II (BDI-II) (time frame: 14 days). The study lists 5 primary outcomes in all. 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 23 Jan 2012.