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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02922725
• Other study ID #: 94176
• Status: Terminated
• Phase: Phase 4
• Start date: November 2016
• Est. completion date: May 2020

Study information

• Verified date: May 2022
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Major Depressive Disorder

Intervention

Drug:
• 5-hydroxytryptophan and Creatine

Other:
• Placebo control

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Brent Michael Kious, MD, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hamilton Depression Rating Scale	The total Hamilton Depression (HAM-D) Rating Scale provides and indication of depression In general, the higher the total score the more severe the depression.; HAM-D score level of depression: 10 - 13 mild; 14-17 mild to moderate; >17 moderate to severe. Range: 0 to 54	8 weeks