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

Primary Purpose

Major Depressive Disorder

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

5-hydroxytryptophan and Creatine

Placebo control

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

25 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

University of Utah

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

Depressed patients receiving study drug

Depressed patients receiving placebo

Healthy Control

Arm Description

Participants diagnosed with MDD

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02922725

First Posted

September 28, 2016

Last Updated

May 26, 2022

Sponsor

Brent Michael Kious, MD, PhD

1. Study Identification

Unique Protocol Identification Number

NCT02922725

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Terminated

Why Stopped

COVID-19 pandemic

Study Start Date

November 2016 (Actual)

Primary Completion Date

May 2020 (Actual)

Study Completion Date

May 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Brent Michael Kious, MD, PhD

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Depressed patients receiving study drug

Arm Type

Active Comparator

Arm Description

Participants diagnosed with MDD

Arm Title

Depressed patients receiving placebo

Arm Type

Placebo Comparator

Arm Description

Participants diagnosed with MDD

Arm Title

Healthy Control

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

5-hydroxytryptophan and Creatine

Intervention Type

Other

Intervention Name(s)

Placebo control

Primary Outcome Measure Information:

Title

Change From Baseline in Hamilton Depression Rating Scale

Description

Time Frame

8 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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 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

Facility Information:

Facility Name

University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84054

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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