5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females
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ClinicalTrials.gov Identifier: NCT02356107 |
Recruitment Status :
Completed
First Posted : February 5, 2015
Results First Posted : January 4, 2018
Last Update Posted : January 29, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depressive Disorder | Drug: 5-hydroxytryptophan and Creatine monohydrate | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females |
Study Start Date : | April 2015 |
Actual Primary Completion Date : | August 2016 |
Actual Study Completion Date : | August 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Open label treatment with 5-HTP and Creatine |
Drug: 5-hydroxytryptophan and Creatine monohydrate |
- 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.

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356107
United States, Utah | |
University of Utah/The Brain Institute | |
Salt Lake City, Utah, United States, 84108 |
Study Director: | Perry F. Renshaw, MD, PhD, MBA | University of Utah |
Responsible Party: | Perry Renshaw, MD, PhD, MBA, University of Utah |
ClinicalTrials.gov Identifier: | NCT02356107 |
Other Study ID Numbers: |
5HTP/Creatine |
First Posted: | February 5, 2015 Key Record Dates |
Results First Posted: | January 4, 2018 |
Last Update Posted: | January 29, 2018 |
Last Verified: | January 2018 |
Hypoxia Depressive Disorder Depressive Disorder, Major Depressive Disorder, Treatment-Resistant Mood Disorders Mental Disorders |
Signs and Symptoms, Respiratory 5-Hydroxytryptophan Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs |