ClinicalTrials.gov
ClinicalTrials.gov Menu

5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Open Label Treatment With 5-HTP and Creatine 5-hydroxytryptophan and Creatine monohydrate

Participant Flow:   Overall Study
    Open Label Treatment With 5-HTP and Creatine
STARTED   15 
COMPLETED   12 
NOT COMPLETED   3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Open Label Treatment With 5-HTP and Creatine 5-hydroxytryptophan and Creatine monohydrate

Baseline Measures
   Open Label Treatment With 5-HTP and Creatine 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      15 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 34  (11.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      15 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      15 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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% 


  Outcome Measures

1.  Primary:   Change From Baseline in Hamilton Depression Rating Scale   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: Brent.Kious@hsc.utah.edu



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