Trial Outcomes & Findings for Placebo-controlled Trial of 5-hydroxytryptophan and Creatine for SSRI or SNRI Augmentation in Treatment Resistant Depression in Females (NCT NCT02922725)
NCT ID: NCT02922725
Last Updated: 2022-05-31
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
8 weeks
Results posted on
2022-05-31
Participant Flow
Participant milestones
| Measure |
Depressed Patients Receiving Study Drug
Participants diagnosed with MDD
5-hydroxytryptophan 100mg PO BID and Creatine monohydrate 5g PO Qday
|
Depressed Patients Receiving Placebo
Participants diagnosed with MDD
Placebo control (fructose 100mg PO BID and fructose 5g PO Qday)
|
No Intervention: Healthy Controls
Healthy controls (no history of depression) recruited for neuroimaging comparison group
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
8
|
|
Overall Study
COMPLETED
|
11
|
12
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Depressed Patients Receiving Study Drug
Participants diagnosed with MDD
5-hydroxytryptophan 100mg PO BID and Creatine monohydrate 5g PO Qday
|
Depressed Patients Receiving Placebo
Participants diagnosed with MDD
Placebo control (fructose 100mg PO BID and fructose 5g PO Qday)
|
No Intervention: Healthy Controls
Healthy controls (no history of depression) recruited for neuroimaging comparison group
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Healthy controls were not asked to complete the depression measure (HAMD) because they did not have depression.
Baseline characteristics by cohort
| Measure |
Depressed Patients Receiving Study Drug
n=11 Participants
Participants diagnosed with MDD
5-hydroxytryptophan and Creatine
|
Depressed Patients Receiving Placebo
n=12 Participants
Participants diagnosed with MDD
Placebo control
|
Healthy Controls
n=8 Participants
Participants with no history of MDD
No intervention
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=11 Participants
|
12 Participants
n=12 Participants
|
8 Participants
n=8 Participants
|
31 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=11 Participants
|
12 Participants
n=12 Participants
|
8 Participants
n=8 Participants
|
31 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=11 Participants
|
12 Participants
n=12 Participants
|
8 Participants
n=8 Participants
|
31 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=11 Participants
|
12 Participants
n=12 Participants
|
8 Participants
n=8 Participants
|
31 Participants
n=31 Participants
|
|
17-Item Hamilton Depression Rating Scale
|
20.5 units on a scale
STANDARD_DEVIATION 3.4 • n=11 Participants • Healthy controls were not asked to complete the depression measure (HAMD) because they did not have depression.
|
20.1 units on a scale
STANDARD_DEVIATION 2.9 • n=12 Participants • Healthy controls were not asked to complete the depression measure (HAMD) because they did not have depression.
|
—
|
20.3 units on a scale
STANDARD_DEVIATION 3.3 • n=23 Participants • Healthy controls were not asked to complete the depression measure (HAMD) because they did not have depression.
|
PRIMARY outcome
Timeframe: 8 weeksThe 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
Outcome measures
| Measure |
Depressed Patients Receiving Study Drug
n=11 Participants
Participants diagnosed with MDD
5-hydroxytryptophan and Creatine
|
Depressed Patients Receiving Placebo
n=12 Participants
Participants diagnosed with MDD
Placebo control
|
|---|---|---|
|
Change From Baseline in Hamilton Depression Rating Scale
|
6.8 units on a scale
Standard Deviation 5.5
|
7.3 units on a scale
Standard Deviation 5.4
|
Adverse Events
Depressed Patients Receiving Study Drug
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Depressed Patients Receiving Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place