Phase 4
Completed N=15
5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females
Source: ClinicalTrials.gov NCT02356107 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcomePrimary: Change From Baseline in Hamilton Depression Rating Scale — 18.9; 7.5 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hamilton Depression Rating Scale |
18.9; 7.5 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02356107). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.