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

NCT ID: NCT02922725

Last Updated: 2022-05-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2020-05-31

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.

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Depressed patients receiving study drug

Participants diagnosed with MDD

Group Type: ACTIVE_COMPARATOR

5-hydroxytryptophan and Creatine

Intervention Type: DRUG

Depressed patients receiving placebo

Participants diagnosed with MDD

Group Type: PLACEBO_COMPARATOR

Placebo control

Intervention Type: OTHER

Healthy Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

5-hydroxytryptophan and Creatine

Intervention Type: DRUG

Placebo control

Intervention Type: OTHER

Eligibility 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

• 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Brent Michael Kious, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Brent Michael Kious, MD, PhD

Instructor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

94176

Identifier Type: -

Identifier Source: org_study_id