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

• Status: Terminated
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brent Kious; Brent Michael Kious, MD, PhD
• Treatments: 5-Hydroxytryptophan

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