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

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Perry Renshaw
• Treatments: 5-Hydroxytryptophan

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