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

• Sponsor: Perry Renshaw (Other)
• Overall Status: Completed
• CT.gov ID: NCT02356107
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Duration (Months): 16
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: 5-hydroxytryptophan and Creatine monohydrate	Phase 4

Detailed Description

Serotonin and creatine are processed separately in the brain, and deficits in these brain biochemicals lead to distinct clinical problems. Therefore, investigators believe that treatment with a combination therapy, which could correct both deficits, would have a synergistic effect in the treatment of hypoxia-related depression and possibly other forms of treatment-resistant depression. Thus, investigators propose to investigate antidepressant efficacy of dietary 5-hydroxytryptophan (5-HTP) and creatine, as a means to restore the brain neurotransmitter and metabolic imbalances linked to chronic hypoxia caused by high altitude residence.

Study Design

• Study Type: Interventional
• 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: Apr 1, 2015
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Hamilton Depression Rating Scale [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah/The Brain Institute	Salt Lake City	Utah	United States	84108

Sponsors and Collaborators

• Perry Renshaw

Investigators

• Study Director: Perry F. Renshaw, MD, PhD, MBA, University of Utah

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Perry Renshaw, MD, PhD, MBA, University of Utah
• ClinicalTrials.gov Identifier: NCT02356107
• Other Study ID Numbers: 5HTP/Creatine
• First Posted: Feb 5, 2015
• Last Update Posted: Jan 29, 2018
• Last Verified: Jan 1, 2018

• Additional relevant MeSH terms: Hypoxia; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; 5-Hydroxytryptophan

Study Results

Participant Flow

Arm/Group Title	Open Label Treatment With 5-HTP and Creatine
Arm/Group Description	5-hydroxytryptophan and Creatine monohydrate
Period Title: Overall Study
STARTED	15
COMPLETED	12
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Open Label Treatment With 5-HTP and Creatine
Arm/Group Description	5-hydroxytryptophan and Creatine monohydrate
Overall Participants	15
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	15 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34 (11.6)
Sex: Female, Male (Count of Participants)
Female	15 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	15 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	15 100%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Hamilton Depression Rating Scale
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Open Label Treatment With 5-HTP and Creatine
Arm/Group Description	5-hydroxytryptophan and Creatine monohydrate
Measure Participants	15
Baseline	18.9 (2.5)
After 8 weeks of treatment	7.5 (4.4)

Adverse Events

Arm/Group Title	Open Label Treatment With 5-HTP and Creatine
Arm/Group Description	5-hydroxytryptophan and Creatine monohydrate
All Cause Mortality
	Open Label Treatment With 5-HTP and Creatine
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Serious Adverse Events
	Open Label Treatment With 5-HTP and Creatine
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Other (Not Including Serious) Adverse Events
	Open Label Treatment With 5-HTP and Creatine
	Affected / at Risk (%)	# Events
Total	7/15 (46.7%)
Endocrine disorders
night sweats/ increased sweating	1/15 (6.7%)	1
General disorders
cold/flu symptoms	1/15 (6.7%)	1
Injury, poisoning and procedural complications
injury/fall	2/15 (13.3%)	2
Renal and urinary disorders
kidney stones	1/15 (6.7%)	1
diagnosis of medullary sponge kidney	1/15 (6.7%)	1
urinary tract infection	1/15 (6.7%)	1

Limitations/Caveats

[Not Specified]

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.