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Trial record 21 of 33 for:    augmentation | "Depressive Disorder, Treatment-Resistant"

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
Sponsor:
Information provided by (Responsible Party):
Perry Renshaw, University of Utah

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Intervention Drug: 5-hydroxytryptophan and Creatine monohydrate
Enrollment 15

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open Label Treatment With 5-HTP and Creatine
Hide Arm/Group Description 5-hydroxytryptophan and Creatine monohydrate
Period Title: Overall Study
Started 15
Completed 12
Not Completed 3
Arm/Group Title Open Label Treatment With 5-HTP and Creatine
Hide Arm/Group Description 5-hydroxytryptophan and Creatine monohydrate
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
34  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
15
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
15
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
15
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Change From Baseline in Hamilton Depression Rating Scale
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Treatment With 5-HTP and Creatine
Hide Arm/Group Description:
5-hydroxytryptophan and Creatine monohydrate
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 18.9  (2.5)
After 8 weeks of treatment 7.5  (4.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open Label Treatment With 5-HTP and Creatine
Hide Arm/Group Description 5-hydroxytryptophan and Creatine monohydrate
All-Cause Mortality
Open Label Treatment With 5-HTP and Creatine
Affected / at Risk (%)
Total   0/15 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Open Label Treatment With 5-HTP and Creatine
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open Label Treatment With 5-HTP and Creatine
Affected / at Risk (%) # Events
Total   7/15 (46.67%)    
Endocrine disorders   
night sweats/ increased sweating  1/15 (6.67%)  1
General disorders   
cold/flu symptoms   1/15 (6.67%)  1
Injury, poisoning and procedural complications   
injury/fall   2/15 (13.33%)  2
Renal and urinary disorders   
kidney stones   1/15 (6.67%)  1
diagnosis of medullary sponge kidney   1/15 (6.67%)  1
urinary tract infection   1/15 (6.67%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Brent Kious, MD, PhD
Organization: University of Utah
Phone: (801) 581-4888
Responsible Party: Perry Renshaw, University of Utah
ClinicalTrials.gov Identifier: NCT02356107     History of Changes
Other Study ID Numbers: 5HTP/Creatine
First Submitted: January 27, 2015
First Posted: February 5, 2015
Results First Submitted: December 5, 2017
Results First Posted: January 4, 2018
Last Update Posted: January 29, 2018