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Sub-chronic Effects of 5-hydroxytryptophan on Mood and Emotional Processing in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01514409
Recruitment Status : Completed
First Posted : January 23, 2012
Last Update Posted : January 23, 2012
Information provided by (Responsible Party):
Northumbria University

Brief 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.

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.

Condition or disease Intervention/treatment Phase
Mood Dietary Supplement: 5-Hydroxytryptophan Dietary Supplement: Pharmaceutical grade silica Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sub-chronic Effects of 5-hydroxytryptophan on Mood and Emotional Processing in Healthy Volunteers: A Randomised Trial
Study Start Date : May 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 5-Hydroxytryptophan Dietary Supplement: 5-Hydroxytryptophan

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.

Placebo Comparator: Placebo Dietary Supplement: Pharmaceutical grade silica
Pharmaceutical grade silica was utilized as placebo

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01514409

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United Kingdom
Northumbria University
Newcastle Upon Tyne, United Kingdom
Sponsors and Collaborators
Northumbria University
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Responsible Party: Northumbria University Identifier: NCT01514409    
Other Study ID Numbers: 24AQ1
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: January 23, 2012
Last Verified: January 2012
Keywords provided by Northumbria University:
Emotional Processing
Emotional Cognition
Nutritional Supplement
Low mood
Additional relevant MeSH terms:
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Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs