5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females

Major Depressive Disorder Clinical Trial

Official title:

5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02356107
• Other study ID #: 5HTP/Creatine
• Status: Completed
• Phase: Phase 4
• First received: January 27, 2015
• Last updated: January 3, 2018
• Start date: April 2015
• Est. completion date: August 2016

Study information

• Verified date: January 2018
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that the administration of two widely available, naturally occurring dietary supplements, 5 hydroxytryptophan and creatine monohydrate, will reduce the severity of depression in individuals exposed to chronic hypoxia by living at altitude. The purpose of this study is to determine if 8 weeks of dietary augmentation with oral 5 g creatine daily and 100 mg 5-HTP twice daily reduces hypoxia-related depressive symptoms measured by the 17-item Hamilton Depression Rating Scale (HAM-D) in women with SSRI or SNRI-resistant depression.

Description:

Serotonin and creatine are processed separately in the brain, and deficits in these brain biochemicals lead to distinct clinical problems. Therefore, investigators believe that treatment with a combination therapy, which could correct both deficits, would have a synergistic effect in the treatment of hypoxia-related depression and possibly other forms of treatment-resistant depression. Thus, investigators propose to investigate antidepressant efficacy of dietary 5-hydroxytryptophan (5-HTP) and creatine, as a means to restore the brain neurotransmitter and metabolic imbalances linked to chronic hypoxia caused by high altitude residence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Female gender, ages 18-64 years inclusive

• Current diagnosis of Major Depressive Disorder identified by the SCID-5-CT

• Current HAM-D17 score of > 15

• Adequate adherence to any FDA approved SSRI or SNRI for at least 8 weeks

Exclusion Criteria:

• Diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, identified by the SCID-5-CT

• History of or current diagnosis of renal disease, such as chronic renal failure, acute renal failure or end stage renal disease

• Diabetes type I or II

• Colitis or diverticulitis

• History of pulmonary disease

• History of fibromyalgia, lupus, eosinophilia myalgia syndrome, dermatomyositis, polymyositis, rheumatoid arthritis, psoriatic arthritis, mixed connective tissue disease, ankylosing spondylitis, or other related rheumatological condition

• Seizure disorder

• Current serious suicide risk identified by the Columbia Severity Suicide Rating Scale

• Current treatment with an antipsychotic, mood stabilizer, or non-SSRI antidepressant

• Positive pregnancy test

• Previous diagnosis of serotonin syndrome

• Use of any excluded drugs or medications including serotonergic drugs or medications

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Hypoxia
• Major Depressive Disorder

Intervention

Drug:
• 5-hydroxytryptophan and Creatine monohydrate

Locations

Country	Name	City	State
United States	University of Utah/The Brain Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Perry Renshaw

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hamilton Depression Rating Scale	The purpose of this study is to determine if 8 weeks of dietary augmentation with oral 5 g creatine daily and 100 mg 5-HTP twice daily reduces hypoxia-related depressive symptoms measured by the 17-item Hamilton Depression Rating Scale (HAM-D) in women with SSRI or SNRI resistant depression. HAM-D (outcome measure) was used to assess the level of depression at baseline and after 8 weeks of using the study drug. The Hamilton Depression Rating Scale ranges from 0 to 50. A score of 0-7 is considered to be normal. A score of 8-13 indicates mild depression. A score of 14-18 indicates moderate depression. Scores higher than 19 indicate severe depression.	8 weeks