Trials Sponsors Conditions Drugs Pricing

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

17-Item Hamilton Depression Rating Scale
Hamilton Depression Rating Scale response: \>=50% reduction in baseline score; maximum possible score is 52, minimum possible score is 0. Higher scores suggest more severe depression.
8 weeks

Secondary Outcomes (1)

Montgomery Asberg Depression Rating Scale
8 weeks

Study Arms (3)

Low Dose 5-hydroxytryptophan and Creatine Monohydrate

EXPERIMENTAL

5-HTP 100mg PO BID plus creatine 5g PO Qday

Drug: Low Dose 5-hydroxytryptophanDrug: Low Dose Creatine MonohydrateDrug: Placebo

High Dose 5-hydroxytryptophan and Creatine Monohydrate

EXPERIMENTAL

5-HTP 200mg PO BID plus creatine 10mg PO Qday

Drug: High Dose 5-hydroxytryptophanDrug: High Dose Creatine Monohydrate

Double Placebo

PLACEBO COMPARATOR

Interventions

Low Dose 5-hydroxytryptophanDrug

5-hydroxytryptophan 100mg PO BID

Also known as: 5-HTP

Low Dose 5-hydroxytryptophan and Creatine Monohydrate

High Dose 5-hydroxytryptophanDrug

5-hydroxytryptophan 200mg PO BID

Also known as: 5-HTP

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adults age 18-65 years inclusive
Current diagnosis of MDD identified by the MINI (Mini Neuropsychiatric Interview)

Sponsors & Collaborators

University of Utah
Otherlead

Study Sites (1)

University of Utah Department of Psychiatry

Salt Lake City, Utah, 84108, United States

RECRUITING

Brent KiousCONTACT8015851418 brent.kious@hsc.utah.edu

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

5-HydroxytryptophanCreatineGlucose

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TryptophanAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsGuanidines

Central Study Contacts

Brent Kious, MD

CONTACT

8015851418 brent.kious@hsc.utah.edu

Hailey Nielson, MS

CONTACT

801-581-3475

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant Professor

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 9, 2023

Study Start

September 28, 2023

Actual (reported)

Primary Completion

July 1, 2027

Estimated

5-HTP and Creatine for Depression R33 Phase

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

Low Dose 5-hydroxytryptophan and Creatine Monohydrate

High Dose 5-hydroxytryptophan and Creatine Monohydrate

Double Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

Low Dose 5-hydroxytryptophan and Creatine Monohydrate

High Dose 5-hydroxytryptophan and Creatine Monohydrate

Double Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations