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

Phase 4

Completed

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Open label treatment with 5-HTP and Creatine	5-hydroxytryptophan and Creatine monohydrate	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hamilton Depression Rating Scale	8 weeks	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. HAM-D (outcome measure) was used to assess the level of depression at baseline and after 8 weeks of using the study drug. The Hamilton Depression Rating Scale ranges from 0 to 50. A score of 0-7 is considered to be normal. A score of 8-13 indicates mild depression. A score of 14-18 indicates moderate depression. Scores higher than 19 indicate severe depression.

Secondary Outcome Measures