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

• ClinicalTrials.gov Identifier: NCT02356107
• Recruitment Status: Completed
• First Posted: February 5, 2015
• Results First Posted: January 4, 2018
• Last Update Posted: January 29, 2018
• Sponsor: Perry Renshaw
• Information provided by (Responsible Party): Perry Renshaw, University of Utah

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Major Depressive Disorder	Drug: 5-hydroxytryptophan and Creatine monohydrate	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females
• Study Start Date: April 2015
• Actual Primary Completion Date: August 2016
• Actual Study Completion Date: August 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Open label treatment with 5-HTP and Creatine	Drug: 5-hydroxytryptophan and Creatine monohydrate

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Hamilton Depression Rating Scale [ Time Frame: 8 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Utah

University of Utah/The Brain Institute

Salt Lake City, Utah, United States, 84108

Sponsors and Collaborators

Perry Renshaw

Investigators

• Study Director: Perry F. Renshaw, MD, PhD, MBA; University of Utah

More Information

• Responsible Party: Perry Renshaw, MD, PhD, MBA, University of Utah
• ClinicalTrials.gov Identifier: NCT02356107
• Other Study ID Numbers: 5HTP/Creatine
• First Posted: February 5, 2015
• Results First Posted: January 4, 2018
• Last Update Posted: January 29, 2018
• Last Verified: January 2018

Additional relevant MeSH terms:

Hypoxia; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Mood Disorders; Mental Disorders; Signs and Symptoms, Respiratory; 5-Hydroxytryptophan; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs