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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

Tracking Information
First Submitted Date  ICMJE January 27, 2015
First Posted Date  ICMJE February 5, 2015
Results First Submitted Date  ICMJE December 5, 2017
Results First Posted Date  ICMJE January 4, 2018
Last Update Posted Date January 29, 2018
Study Start Date  ICMJE April 2015
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2018)
Change From Baseline in Hamilton Depression Rating Scale [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2015)
Change From Baseline in Hamilton Depression Rating Scale [ Time Frame: 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-resistant depression
Change History Complete list of historical versions of study NCT02356107 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females
Official Title  ICMJE 5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Drug: 5-hydroxytryptophan and Creatine monohydrate
Study Arms  ICMJE Experimental: Open label treatment with 5-HTP and Creatine
Intervention: Drug: 5-hydroxytryptophan and Creatine monohydrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2016)
15
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2015)
16
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02356107
Other Study ID Numbers  ICMJE 5HTP/Creatine
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Perry Renshaw, University of Utah
Study Sponsor  ICMJE Perry Renshaw
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Perry F. Renshaw, MD, PhD, MBA University of Utah
PRS Account University of Utah
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP