5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Condition or disease
Major Depressive Disorder
Drug: 5-hydroxytryptophan and Creatine monohydrate
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.
Change From Baseline in Hamilton Depression Rating Scale [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 64 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
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