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

NCT02922725 | Terminated Phase 4 Results DMC

• 1 other identifier: 94176
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Depressed patients receiving study drug

ACTIVE COMPARATOR

Participants diagnosed with MDD

Drug: 5-hydroxytryptophan and Creatine

Depressed patients receiving placebo

PLACEBO COMPARATOR

Participants diagnosed with MDD

Other: Placebo control

Healthy Control

NO INTERVENTION

Interventions

5-hydroxytryptophan and Creatine DRUG

Depressed patients receiving study drug

Placebo control OTHER

Depressed patients receiving placebo

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brent Michael Kious, MD, PhD: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84054, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

5-Hydroxytryptophan; Creatine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptophan; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Guanidines; Amidines; Organic Chemicals

Limitations and Caveats

Difficulties with recruitment suggest that the study may have been underpowered to detect an effect.

Results Point of Contact

• Title: Brent M. Kious
• Organization: University of Utah

brent.kious@hsc.utah.edu

801-585-1418

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 4, 2016
• Study Start: November 1, 2016
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: May 31, 2022
• Results First Posted: May 31, 2022

Record last verified: 2022-05

Locations

US (1)