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NCT02356107 · ClinicalTrials.gov registry record · Phase 4
5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females
A Phase 4 study of Major Depressive Disorder, sponsored by Perry Renshaw.
- Completed
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT02356107: Completed Phase 4 study of Major Depressive Disorder, sponsored by Perry Renshaw.
NCT02356107 is a Phase 4 study of Major Depressive Disorder that has completed, run by Perry Renshaw. The registered enrollment target is 15 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02356107, a Phase 4 study of Major Depressive Disorder, has completed, sponsored by Perry Renshaw.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 considere
Conditions Studied
Interventions
- DRUG 5-hydroxytryptophan and Creatine monohydrate
Study Locations (1)
Utah
- University of Utah/The Brain Institute - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2015-04 |
| Est. Completion | 2016-08 |
| Phase | Phase 4 |
What the finished NCT02356107 record still lists
NCT02356107 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 1 intervention - of which 5-hydroxytryptophan and Creatine monohydrate is the first listed.
NCT02356107 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT02356107 about?
NCT02356107 is a clinical study titled "5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females". 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 t...
What is the current status of trial NCT02356107?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2015-04. Estimated completion is 2016-08.
What conditions does trial NCT02356107 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT02356107?
The interventions under investigation include: 5-hydroxytryptophan and Creatine monohydrate (DRUG).
Who is sponsoring clinical trial NCT02356107?
This trial is sponsored by Perry Renshaw, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02356107 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02356107's enrollment target sits among peer trials
15 261st of 282 higher than 20 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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