5-hydroxytryptophan and creatine for treatment resistant depression associated with hypoxia in females

Principal Investigator: Brent Kious
Keywords: Depression , Treatment resistence , 5-hydroxytryptophan , Creatine Monohydrate Department: Psychiatry
IRB Number: 00080288 Co Investigator:  
Specialty: Psychiatry
Sub Specialties: Mood Disorders
Recruitment Status: Completed

Contact Information

Hana  Sabic

Brief Summary

We 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 significantly reduces hypoxia-related depressive symptoms measured by the 17-item Hamilton Depression Rating Scale (HAM-D) in women with SSRI or SNRI-resistant depression.

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 > 16
  • 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
  • Breastfeeding
  • Previous diagnosis of serotonin syndrome
  • Use of any excluded drugs or medications including serotonergic drugs or medications