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

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.

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