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

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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:
Information provided by (Responsible Party):
Perry Renshaw, University of Utah

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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

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


Outcome Measures
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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
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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
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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 ClinicalTrials.gov identifier (NCT number): NCT02356107


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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Hypoxia
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
 Mental Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
5-Hydroxytryptophan
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs