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Trial record 11 of 33 for:    augmentation | "Depressive Disorder, Treatment-Resistant"

Placebo-controlled Trial of 5-hydroxytryptophan and Creatine for SSRI or SNRI Augmentation in Treatment Resistant Depression in Females

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ClinicalTrials.gov Identifier: NCT02922725
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Brent Kious, University of Utah

Brief Summary:
The investigators propose to determine if 8 weeks of dietary augmentation with oral 5g creatine monohydrate daily and 100 mg of 5-hydroxytryptophan (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, combined with the examination of changes in functional connectivity based on resting-state fMRI and changes in brain metabolism inferred from phosphorus-31 magnetic resonance spectroscopy.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: 5-hydroxytryptophan and Creatine Other: Placebo control 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Trial of 5-hydroxytryptophan and Creatine for SSRI or SNRI Augmentation in Treatment Resistant Depression Associated With Hypobaric Hypoxia in Females
Study Start Date : November 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Depressed patients receiving study drug
Participants diagnosed with MDD
Drug: 5-hydroxytryptophan and Creatine
Placebo Comparator: Depressed patients receiving placebo
Participants diagnosed with MDD
Other: Placebo control
No Intervention: Healthy Control



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female gender, ages 25-40 years inclusive
  • Current diagnosis of Major Depressive Disorder identified by the SCID-I
  • Current HAM-D17 score of > 16
  • Adequate adherence to any FDA approved SSRI or SNRI for at least 8 weeks
  • Right-handed

Healthy Controls Inclusion criteria:

  • Female gender, ages 25-40 inclusive
  • No current or past DSM-5 diagnosis, as determined by clinical and structured interviews

Exclusion Criteria:

  • Any non-MDD and non-anxiety psychiatric diagnosis, as identified by the SCID-I
  • 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
  • Current colitis or diverticulitis
  • History of or current pulmonary disease
  • History of cardiac disease or QTc > 500ms
  • History of fibromyalgia, lupus, eosinophilia-myalgia syndrome, dermatomyositis, polymyositis, rheumatoid arthritis, psoriatic arthritis, mixed connective tissue disease, ankylosing spondylitis, or other related rheumatological condition
  • History of or current 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, pregnancy, failure to use adequate birth control method
  • Previous diagnosis of serotonin syndrome or evidence of serotonin syndrome
  • Use of any excluded drugs or medications including serotonergic drugs or medications (Table 2)
  • Pre-existing eosinophilia (absolute eosinophil count > 500/uL)
  • Contraindications to MRI: ferromagnetic implants, implanted devices, claustrophobia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922725


Contacts
Contact: Hana Sabic 801-587-0332 hana.sabic@utah.edu

Locations
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84054
Contact: Hana Sabic    801-587-0332    hana.sabic@utah.edu   
Sponsors and Collaborators
Brent Kious

Responsible Party: Brent Kious, Instructor, University of Utah
ClinicalTrials.gov Identifier: NCT02922725     History of Changes
Other Study ID Numbers: 94176
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Depressive Disorder, Treatment-Resistant
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
5-Hydroxytryptophan
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs