5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females
| Status: | Completed |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 1/31/2018 |
| Start Date: | April 2015 |
| End Date: | August 2016 |
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
