Trial Outcomes & Findings for 5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females (NCT NCT02356107)

NCT ID: NCT02356107

Last Updated: 2018-01-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 15 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2018-01-29

Participant Flow

Participant milestones

Measure	Open Label Treatment With 5-HTP and Creatine 5-hydroxytryptophan and Creatine monohydrate
Overall Study STARTED	15
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Open Label Treatment With 5-HTP and Creatine n=15 Participants 5-hydroxytryptophan and Creatine monohydrate
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	34 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Open Label Treatment With 5-HTP and Creatine n=15 Participants 5-hydroxytryptophan and Creatine monohydrate
Change From Baseline in Hamilton Depression Rating Scale Baseline	18.9 units on a scale Standard Deviation 2.5
Change From Baseline in Hamilton Depression Rating Scale After 8 weeks of treatment	7.5 units on a scale Standard Deviation 4.4

Adverse Events

Open Label Treatment With 5-HTP and Creatine

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Open Label Treatment With 5-HTP and Creatine n=15 participants at risk 5-hydroxytryptophan and Creatine monohydrate
General disorders cold/flu symptoms	6.7% 1/15 • Number of events 1
Renal and urinary disorders kidney stones	6.7% 1/15 • Number of events 1
Renal and urinary disorders diagnosis of medullary sponge kidney	6.7% 1/15 • Number of events 1
Injury, poisoning and procedural complications injury/fall	13.3% 2/15 • Number of events 2
Endocrine disorders night sweats/ increased sweating	6.7% 1/15 • Number of events 1
Renal and urinary disorders urinary tract infection	6.7% 1/15 • Number of events 1

Additional Information

Brent Kious, MD, PhD

University of Utah

Phone: (801) 581-4888

Email: Brent.Kious@hsc.utah.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place