Clinical trial NCT02356107: 5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females
Official title: 5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2015-02-05
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in Hamilton Depression Rating Scale
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah/The Brain Institute
state: Utah
Study officials:
affiliation: University of Utah
name: Perry F. Renshaw, MD, PhD, MBA
role: STUDY_DIRECTOR
References: