Trial Outcomes & Findings for Does Enhanced Glutamate Transporter Function Produce Antidepressant Effects in People With Major Depression? (NCT NCT02049385)
NCT ID: NCT02049385
Last Updated: 2017-10-13
Results Overview
Change in Montgomery Asberg Depression Rating Scale (MADRS) from baseline to 7 days post-treatment. The range of values is from 0 - 60, with a higher score indicating increased depressive symptoms. A score of 7-19 indicates mild depression; 20-34 indicates moderate depression; \>34 indicates severe depression.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
7 days
Results posted on
2017-10-13
Participant Flow
Participant milestones
| Measure |
Diazoxide, Then Placebo
Subjects received 200-400 mg daily of diazoxide orally for three weeks; the dose was adjusted depending on side effects and response.
|
Placebo, Then Diazoxide
Subjects received a matched placebo for three weeks.
|
|---|---|---|
|
First Intervention
STARTED
|
4
|
2
|
|
First Intervention
COMPLETED
|
1
|
2
|
|
First Intervention
NOT COMPLETED
|
3
|
0
|
|
Second Intervention
STARTED
|
1
|
2
|
|
Second Intervention
COMPLETED
|
1
|
0
|
|
Second Intervention
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does Enhanced Glutamate Transporter Function Produce Antidepressant Effects in People With Major Depression?
Baseline characteristics by cohort
| Measure |
All Participants
n=6 Participants
Subjects received 200-400 mg daily of diazoxide orally for three weeks; the dose was, adjusted depending on side effects and response.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: The analysis included those subjects who started treatment and completed treatment with Diazoxide or Placebo through at least 7 days.
Change in Montgomery Asberg Depression Rating Scale (MADRS) from baseline to 7 days post-treatment. The range of values is from 0 - 60, with a higher score indicating increased depressive symptoms. A score of 7-19 indicates mild depression; 20-34 indicates moderate depression; \>34 indicates severe depression.
Outcome measures
| Measure |
Diazoxide
n=6 Participants
Subjects received 200-400 mg daily of diazoxide orally for three weeks; the dose was adjusted depending on side effects and response.
|
Placebo
n=3 Participants
Subjects received a matched placebo for three weeks.
|
|---|---|---|
|
MADRS Change at Day 7
|
0 percentage of change in units of scale
Interval 0.0 to 100.0
|
10 percentage of change in units of scale
Interval 0.0 to 100.0
|
Adverse Events
Diazoxide
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diazoxide
n=6 participants at risk
Subjects received 200-400 mg daily of diazoxide orally for three weeks; the dose was adjusted depending on side effects and response.
|
Placebo
n=3 participants at risk
Subjects received a matched placebo for three weeks.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
|
Cardiac disorders
Chest pain
|
16.7%
1/6 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Cardiac disorders
Tachycardia
|
16.7%
1/6 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
16.7%
1/6 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • 12 weeks
|
66.7%
2/3 • 12 weeks
|
|
General disorders
Discomfort
|
16.7%
1/6 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
|
Metabolism and nutrition disorders
Weight increased
|
33.3%
2/6 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
|
Metabolism and nutrition disorders
Oedema
|
50.0%
3/6 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Chills
|
0.00%
0/6 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
1/6 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
16.7%
1/6 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • 12 weeks
|
66.7%
2/3 • 12 weeks
|
|
Nervous system disorders
Akathisia
|
16.7%
1/6 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Nervous system disorders
Headache
|
66.7%
4/6 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Nervous system disorders
Irregular sleep phase
|
0.00%
0/6 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/6 • 12 weeks
|
66.7%
2/3 • 12 weeks
|
|
Nervous system disorders
Sedation
|
16.7%
1/6 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Psychiatric disorders
Decreased activity
|
0.00%
0/6 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Irregular breathing
|
16.7%
1/6 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/6 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
1/6 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
16.7%
1/6 • 12 weeks
|
0.00%
0/3 • 12 weeks
|
|
Vascular disorders
Dizziness
|
33.3%
2/6 • 12 weeks
|
33.3%
1/3 • 12 weeks
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • 12 weeks
|
66.7%
2/3 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place