Principal Investigator: Brent Kious
Keywords: Depression , Treatment resistence , 5-hydroxytryptophan , Creatine Monohydrate , altitude Department: Psychiatry
IRB Number: 00094176 Co Investigator: Younghoon Sung
Specialty: Psychiatry
Sub Specialties: Mood Disorders
Recruitment Status: Completed

Contact Information

Hana Sabic

Simple Summary

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

Inclusion Criteria

  • Female gender, ages 18-60 years inclusive**
  • Current diagnosis of Major Depressive Disorder identified by the SCID-I
  • At least moderate depression (Current HAM-D17 score of > 16) despite adequate adherence  to any FDA approved SSRI or SNRI for at least 8 weeks

**The age range of the study is dictated primarily by the period of maximal cerebral anatomic stability to improve our imaging findings; below age 25, there is excessive brain development which could make results harder to interpret; above age 40, there is often the onset of mild neurodegeneration which can also complicate imaging interpretation.


Healthy Controls Inclusion criteria:

  • Female gender, ages 18-60 inclusive
  • No current or past DSM-5 diagnosis, as determined by clinical and structured interviews

Exclusion Criteria

  • Any non-MDD and non-anxiety psychiatric diagnosis, as identified by the SCID-I
  • 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
  • Current colitis or diverticulitis
  • History of or current pulmonary disease
  • History of cardiac disease or QTc > 500ms
  • History of fibromyalgia, lupus, eosinophilia-myalgia syndrome, dermatomyositis, polymyositis, rheumatoid arthritis, psoriatic arthritis, mixed connective tissue disease, ankylosing spondylitis, or other related rheumatological condition
  • History of or current 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 except for bupropion as an augmenting agent
  • Positive pregnancy test, pregnancy, failure to use adequate birth control method
  • Previous diagnosis of serotonin syndrome or evidence of serotonin syndrome
  • Use of any excluded drugs or medications including serotonergic drugs or medications
  • Pre-existing eosinophilia (absolute eosinophil count > 500/uL)
  • Serotonin modulators (except for trazodone up to 200mg at bedtime)

Participant Reimbursement

1.$25 - Screening 2.$65 - Baseline visit (includes $50 compensation for MRI)3.$15 - Treatment phase visits (weeks 1, 2, 4, 6) 4.$65 – Treatment week 8 (includes $50 compensation for MRI)5.$10 – Follow-up visits (weeks 10, 12) (total $20)Healthy MRI controls will receive compensation on the above schedule for screening, baseline, and Week 8 visits only, for a total of $155.