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

NCT02356107 | Completed Phase 4 Results

• 1 other identifier: 5HTP/Creatine
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Open label treatment with 5-HTP and Creatine

EXPERIMENTAL

Drug: 5-hydroxytryptophan and Creatine monohydrate

Interventions

5-hydroxytryptophan and Creatine monohydrate DRUG

Open label treatment with 5-HTP and Creatine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Perry Renshaw: lead

Study Sites (1)

University of Utah/The Brain Institute

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

5-Hydroxytryptophan; Creatine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptophan; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Brent Kious, MD, PhD
• Organization: University of Utah

Brent.Kious@hsc.utah.edu

(801) 581-4888

Study Officials

• Perry F. Renshaw, MD, PhD, MBA

  University of Utah

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, MBA

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: February 5, 2015
• Study Start: April 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 29, 2018
• Results First Posted: January 4, 2018

Record last verified: 2018-01

Locations

US (1)