Trial Outcomes & Findings for 5-HTP and Creatine for Depression (NCT NCT04395183)

Last Updated: 2024-07-23

Results Overview

Hamilton Depression Rating Scale response rate: proportion of participants exhibiting \>=50% reduction in baseline score; maximum possible score is 52, minimum possible score is 0. Higher scores suggest more severe depression.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

8 weeks

Results posted on

2024-07-23

Participant Flow

Participant milestones

Participant milestones
Measure	5-HTP + Placebo 5-hydroxytryptophan 100mg PO BID plus placebo matched to creatine monohydrate 5-Hydroxytryptophan 100 MG: 5-HTP 100mg PO BID placebo matched to 5-HTP: placebo matched to 5-HTP	Creatine + Placebo Creatine 5g PO qday plus placebo matched to 5-HTP Creatine monohydrate: Creatine monohydrate 5g PO qday placebo matched to 5-HTP: placebo matched to 5-HTP	Creatine + 5-HTP Creatine 5g PO qday plus 5-hydroxytryptophan 100mg PO BID 5-Hydroxytryptophan 100 MG: 5-HTP 100mg PO BID Creatine monohydrate: Creatine monohydrate 5g PO qday	Double Placebo Creatine-matched placebo and 5-HTP-matched placebo Placebo: Dextrose either as loose powder (matched to creatine) or encapsulated (matched to 5-HTP)
Overall Study STARTED	11	10	11	11
Overall Study COMPLETED	10	10	9	9
Overall Study NOT COMPLETED	1	0	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	5-HTP + Placebo 5-hydroxytryptophan 100mg PO BID plus placebo matched to creatine monohydrate 5-Hydroxytryptophan 100 MG: 5-HTP 100mg PO BID placebo matched to 5-HTP: placebo matched to 5-HTP	Creatine + Placebo Creatine 5g PO qday plus placebo matched to 5-HTP Creatine monohydrate: Creatine monohydrate 5g PO qday placebo matched to 5-HTP: placebo matched to 5-HTP	Creatine + 5-HTP Creatine 5g PO qday plus 5-hydroxytryptophan 100mg PO BID 5-Hydroxytryptophan 100 MG: 5-HTP 100mg PO BID Creatine monohydrate: Creatine monohydrate 5g PO qday	Double Placebo Creatine-matched placebo and 5-HTP-matched placebo Placebo: Dextrose either as loose powder (matched to creatine) or encapsulated (matched to 5-HTP)
Overall Study Withdrawal by Subject	1	0	2	2

Baseline Characteristics

5-HTP and Creatine for Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	5-HTP + Placebo n=11 Participants 5-hydroxytryptophan 100mg PO BID plus placebo matched to creatine monohydrate 5-Hydroxytryptophan 100 MG: 5-HTP 100mg PO BID placebo matched to 5-HTP: placebo matched to 5-HTP	Creatine + Placebo n=10 Participants Creatine 5g PO qday plus placebo matched to 5-HTP Creatine monohydrate: Creatine monohydrate 5g PO qday placebo matched to 5-HTP: placebo matched to 5-HTP	Creatine + 5-HTP n=11 Participants Creatine 5g PO qday plus 5-hydroxytryptophan 100mg PO BID 5-Hydroxytryptophan 100 MG: 5-HTP 100mg PO BID Creatine monohydrate: Creatine monohydrate 5g PO qday	Double Placebo n=11 Participants Creatine-matched placebo and 5-HTP-matched placebo Placebo: Dextrose either as loose powder (matched to creatine) or encapsulated (matched to 5-HTP)	Total n=43 Participants Total of all reporting groups
Age, Continuous	33.5 years STANDARD_DEVIATION 5.5 • n=99 Participants	35.5 years STANDARD_DEVIATION 5.8 • n=107 Participants	33.9 years STANDARD_DEVIATION 4.9 • n=206 Participants	30.8 years STANDARD_DEVIATION 5.5 • n=7 Participants	33.5 years STANDARD_DEVIATION 5.5 • n=31 Participants
Sex: Female, Male Female	8 Participants n=99 Participants	9 Participants n=107 Participants	9 Participants n=206 Participants	6 Participants n=7 Participants	32 Participants n=31 Participants
Sex: Female, Male Male	3 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants	5 Participants n=7 Participants	11 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) White	10 Participants n=99 Participants	9 Participants n=107 Participants	11 Participants n=206 Participants	10 Participants n=7 Participants	40 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	2 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: The number of participants analyzed is less than the number of participants enrolled because of attrition in each group. Arm 1 lost one participant. Arm 2 lost one participant. Arm 3 lost two participants. Arm 4 lost two participants.

Outcome measures

Outcome measures
Measure	5-HTP + Placebo n=10 Participants 5-hydroxytryptophan 100mg PO BID plus placebo matched to creatine monohydrate 5-Hydroxytryptophan 100 MG: 5-HTP 100mg PO BID placebo matched to 5-HTP: placebo matched to 5-HTP	Creatine + Placebo n=9 Participants Creatine 5g PO qday plus placebo matched to 5-HTP Creatine monohydrate: Creatine monohydrate 5g PO qday placebo matched to 5-HTP: placebo matched to 5-HTP	Creatine + 5-HTP n=9 Participants Creatine 5g PO qday plus 5-hydroxytryptophan 100mg PO BID 5-Hydroxytryptophan 100 MG: 5-HTP 100mg PO BID Creatine monohydrate: Creatine monohydrate 5g PO qday	Double Placebo n=9 Participants Creatine-matched placebo and 5-HTP-matched placebo Placebo: Dextrose either as loose powder (matched to creatine) or encapsulated (matched to 5-HTP)
17-Item Hamilton Depression Rating Scale Responders	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 8 weeks

Montgomery Asberg Depression Rating Scale Response Rate. Proportion of responders. Response is a \>=50% reduction in baseline score; minimum score 0; maximum score 60; higher scores suggest more severe depression

Outcome measures

Outcome measures
Measure	5-HTP + Placebo n=10 Participants 5-hydroxytryptophan 100mg PO BID plus placebo matched to creatine monohydrate 5-Hydroxytryptophan 100 MG: 5-HTP 100mg PO BID placebo matched to 5-HTP: placebo matched to 5-HTP	Creatine + Placebo n=9 Participants Creatine 5g PO qday plus placebo matched to 5-HTP Creatine monohydrate: Creatine monohydrate 5g PO qday placebo matched to 5-HTP: placebo matched to 5-HTP	Creatine + 5-HTP n=9 Participants Creatine 5g PO qday plus 5-hydroxytryptophan 100mg PO BID 5-Hydroxytryptophan 100 MG: 5-HTP 100mg PO BID Creatine monohydrate: Creatine monohydrate 5g PO qday	Double Placebo n=9 Participants Creatine-matched placebo and 5-HTP-matched placebo Placebo: Dextrose either as loose powder (matched to creatine) or encapsulated (matched to 5-HTP)
Montgomery Asberg Depression Rating Scale Response Rate	0 Participants	2 Participants	2 Participants	2 Participants

Adverse Events

5-HTP + Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Creatine + Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Creatine + 5-HTP

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Double Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	5-HTP + Placebo n=11 participants at risk 5-hydroxytryptophan 100mg PO BID plus placebo matched to creatine monohydrate 5-Hydroxytryptophan 100 MG: 5-HTP 100mg PO BID placebo matched to 5-HTP: placebo matched to 5-HTP	Creatine + Placebo n=10 participants at risk Creatine 5g PO qday plus placebo matched to 5-HTP Creatine monohydrate: Creatine monohydrate 5g PO qday placebo matched to 5-HTP: placebo matched to 5-HTP	Creatine + 5-HTP n=11 participants at risk Creatine 5g PO qday plus 5-hydroxytryptophan 100mg PO BID 5-Hydroxytryptophan 100 MG: 5-HTP 100mg PO BID Creatine monohydrate: Creatine monohydrate 5g PO qday	Double Placebo n=11 participants at risk Creatine-matched placebo and 5-HTP-matched placebo Placebo: Dextrose either as loose powder (matched to creatine) or encapsulated (matched to 5-HTP)
Gastrointestinal disorders Nausea	36.4% 4/11 • Number of events 4 • 8 weeks	30.0% 3/10 • Number of events 3 • 8 weeks	36.4% 4/11 • Number of events 4 • 8 weeks	27.3% 3/11 • Number of events 3 • 8 weeks
Nervous system disorders Headache	9.1% 1/11 • Number of events 1 • 8 weeks	0.00% 0/10 • 8 weeks	0.00% 0/11 • 8 weeks	9.1% 1/11 • Number of events 1 • 8 weeks

Additional Information

Brent Kious, MD, PhD

University of Utah

Phone: 801-585-1418

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place