Major Depressive Disorder
Conditions
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.
Interventions
DRUG5-hydroxytryptophan and Creatine monohydrate
Sponsors
Perry Renshaw
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open Label Treatment With 5-HTP and Creatine 5-hydroxytryptophan and Creatine monohydrate | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Open Label Treatment With 5-HTP and Creatine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 34 years STANDARD_DEVIATION 11.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 7 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Change From Baseline in Hamilton Depression Rating Scale
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.
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label Treatment With 5-HTP and Creatine | Change From Baseline in Hamilton Depression Rating Scale | Baseline | 18.9 units on a scale | Standard Deviation 2.5 |
| Open Label Treatment With 5-HTP and Creatine | Change From Baseline in Hamilton Depression Rating Scale | After 8 weeks of treatment | 7.5 units on a scale | Standard Deviation 4.4 |