Back to results5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
5-hydroxytryptophan and Creatine monohydrate
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
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
Sites / Locations
- University of Utah/The Brain Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open label treatment with 5-HTP and Creatine
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02356107
Brief Title
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
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Perry Renshaw
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open label treatment with 5-HTP and Creatine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
5-hydroxytryptophan and Creatine monohydrate
Primary Outcome Measure Information:
Title
Change From Baseline in Hamilton Depression Rating Scale
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perry F. Renshaw, MD, PhD, MBA
Organizational Affiliation
University of Utah
Official's Role
Study Director
Facility Information:
Facility Name
University of Utah/The Brain Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
12. IPD Sharing Statement
Learn more about this trial
5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females
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