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

Last updated: January 3, 2018
Sponsor: Perry Renshaw
Overall Status: Completed

Phase

4

Condition

Affective Disorders

Mood Disorders

Depression (Major/severe)

Treatment

N/A

Clinical Study ID

NCT02356107
5HTP/Creatine
  • Ages 18-64
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

  • History of or current diagnosis of renal disease, such as chronic renal failure, acuterenal 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 tissuedisease, 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

Study Design

Total Participants: 15
Study Start date:
April 01, 2015
Estimated Completion Date:
August 31, 2016

Study 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.

Connect with a study center

  • University of Utah/The Brain Institute

    Salt Lake City, Utah 84108
    United States

    Site Not Available

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