Trial Outcomes & Findings for Study Using Pregnenolone to Treat Bipolar Depression (NCT NCT01409096)
NCT ID: NCT01409096
Last Updated: 2016-03-31
Results Overview
The HRSD is an observer-rated measure of depressive symptomatology. Minimum: 0; Maximum: 50; Better outcome: lower score; Normal score: 7 or less.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
12 weeks
Results posted on
2016-03-31
Participant Flow
Participant milestones
| Measure |
Pregnenolone
This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.
Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system.
|
Placebo
The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.
Placebo: Inactive ingredient matching the active medication in appearance.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
38
|
35
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Using Pregnenolone to Treat Bipolar Depression
Baseline characteristics by cohort
| Measure |
Pregnenolone
n=38 Participants
This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.
Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system.
|
Placebo
n=35 Participants
The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.
Placebo: Inactive ingredient matching the active medication in appearance.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.2 years
STANDARD_DEVIATION 8.5 • n=99 Participants
|
44.1 years
STANDARD_DEVIATION 10.4 • n=107 Participants
|
43.6 years
STANDARD_DEVIATION 9.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African-American
|
18 participants
n=99 Participants
|
15 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
18 participants
n=99 Participants
|
16 participants
n=107 Participants
|
34 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 participants
n=99 Participants
|
4 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Bipolar Diagnosis
Bipolar I
|
16 participants
n=99 Participants
|
15 participants
n=107 Participants
|
31 participants
n=206 Participants
|
|
Bipolar Diagnosis
Bipolar II
|
21 participants
n=99 Participants
|
17 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Bipolar Diagnosis
Bipolar Not Otherwise Specified
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Age of onset of mood symptoms
|
26.4 years
STANDARD_DEVIATION 9.0 • n=99 Participants
|
26.7 years
STANDARD_DEVIATION 7.3 • n=107 Participants
|
26.7 years
STANDARD_DEVIATION 8.22 • n=206 Participants
|
|
Concomitant Medications: Lithium
Lithium
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Concomitant Medications: Lithium
No Lithium
|
33 participants
n=99 Participants
|
31 participants
n=107 Participants
|
64 participants
n=206 Participants
|
|
Concomitant Medications: Anticonvulsant
Anticonvulsants
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Concomitant Medications: Anticonvulsant
No anticonvulsants
|
28 participants
n=99 Participants
|
25 participants
n=107 Participants
|
53 participants
n=206 Participants
|
|
Concomitant Medications: Antidepressant
Antidepressants
|
21 participants
n=99 Participants
|
22 participants
n=107 Participants
|
43 participants
n=206 Participants
|
|
Concomitant Medications: Antidepressant
No antidepressants
|
17 participants
n=99 Participants
|
13 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Concomitant Medications: Antipsychotic
Antipsychotic
|
17 participants
n=99 Participants
|
18 participants
n=107 Participants
|
35 participants
n=206 Participants
|
|
Concomitant Medications: Antipsychotic
No antipsychotic
|
21 participants
n=99 Participants
|
17 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Concomitant Medications: Sedative/hypnotic/anxiolytic
Sedative/hypnotic/anxiolytic
|
16 participants
n=99 Participants
|
20 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Concomitant Medications: Sedative/hypnotic/anxiolytic
No Sedative/hypnotic/anxiolytic
|
22 participants
n=99 Participants
|
15 participants
n=107 Participants
|
37 participants
n=206 Participants
|
|
Concomitant medications: Stimulant
Stimulant
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Concomitant medications: Stimulant
No stimulant
|
38 participants
n=99 Participants
|
34 participants
n=107 Participants
|
72 participants
n=206 Participants
|
|
Concomitant medications: None
No concomitant medications
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Concomitant medications: None
Concomitant medication
|
31 participants
n=99 Participants
|
29 participants
n=107 Participants
|
60 participants
n=206 Participants
|
|
Hamilton Rating Scale for Depression (HRSD)
|
21.3 units on a scale
STANDARD_DEVIATION 4.0 • n=99 Participants
|
23.5 units on a scale
STANDARD_DEVIATION 4.6 • n=107 Participants
|
22.4 units on a scale
STANDARD_DEVIATION 4.3 • n=206 Participants
|
|
Inventory of Depressive Symtomatology-Self Report (IDS-SR)
|
38.0 units on a scale
STANDARD_DEVIATION 14.5 • n=99 Participants
|
47.5 units on a scale
STANDARD_DEVIATION 14.5 • n=107 Participants
|
42.7 units on a scale
STANDARD_DEVIATION 15.2 • n=206 Participants
|
|
Young Mania Rating Scale (YMRS)
|
10.1 units on a scale
STANDARD_DEVIATION 4.7 • n=99 Participants
|
10.4 units on a scale
STANDARD_DEVIATION 4.3 • n=107 Participants
|
10.1 units on a scale
STANDARD_DEVIATION 4.3 • n=206 Participants
|
|
Hamilton Rating Scale for Anxiety (HRSA)
|
19.4 units on a scale
STANDARD_DEVIATION 9.8 • n=99 Participants
|
22.8 units on a scale
STANDARD_DEVIATION 8.1 • n=107 Participants
|
21.1 units on a scale
STANDARD_DEVIATION 9.2 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe HRSD is an observer-rated measure of depressive symptomatology. Minimum: 0; Maximum: 50; Better outcome: lower score; Normal score: 7 or less.
Outcome measures
| Measure |
Pregnenolone
n=38 Participants
This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.
Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system.
|
Placebo
n=35 Participants
The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.
Placebo: Inactive ingredient matching the active medication in appearance.
|
|---|---|---|
|
The 17-item Hamilton Rating Scale for Depression (HRSD17)
|
9.18 units on a scale
Standard Error 1.41
|
9.41 units on a scale
Standard Error 1.35
|
SECONDARY outcome
Timeframe: 12 weeksIDS-SR is a self reported 30 item assessment to diagnose a major depressive episode. Score: Minimum: 0 Maximum: 84 Lower score associated with better outcome
Outcome measures
| Measure |
Pregnenolone
n=38 Participants
This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.
Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system.
|
Placebo
n=35 Participants
The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.
Placebo: Inactive ingredient matching the active medication in appearance.
|
|---|---|---|
|
Inventory of Depressive Symptomatology-Self Report (IDS-SR)
|
15.78 units on a scale
Standard Error 2.64
|
18.23 units on a scale
Standard Error 2.54
|
SECONDARY outcome
Timeframe: 12 weeksThis is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe). Score: Minimum: 0 Maximum: 60 Lower score associated with better outcome
Outcome measures
| Measure |
Pregnenolone
n=38 Participants
This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.
Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system.
|
Placebo
n=35 Participants
The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.
Placebo: Inactive ingredient matching the active medication in appearance.
|
|---|---|---|
|
Young Mania Rating Scale (YMRS)
|
5.84 units on a scale
Standard Error 1.09
|
6.63 units on a scale
Standard Error 1.05
|
SECONDARY outcome
Timeframe: 12 weeksThe scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where less than 17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Outcome measures
| Measure |
Pregnenolone
n=38 Participants
This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.
Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system.
|
Placebo
n=35 Participants
The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.
Placebo: Inactive ingredient matching the active medication in appearance.
|
|---|---|---|
|
Hamilton Rating Scale for Anxiety (HRSA)
|
8.80 units on a scale
Standard Error 1.63
|
10.32 units on a scale
Standard Error 1.57
|
Adverse Events
Pregnenolone
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregnenolone
n=38 participants at risk
This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.
Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system.
|
Placebo
n=35 participants at risk
The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.
Placebo: Inactive ingredient matching the active medication in appearance.
|
|---|---|---|
|
Eye disorders
Corneal ulceration
|
2.6%
1/38 • Number of events 1
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
Skin abscess followed by allergic reaction to antibiotic used to treat it
|
2.6%
1/38 • Number of events 1
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
2.6%
1/38 • Number of events 1
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
2.6%
1/38 • Number of events 1
|
0.00%
0/35
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/38
|
2.9%
1/35 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injuries secondary to motor vehicle accident
|
0.00%
0/38
|
2.9%
1/35 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/38
|
2.9%
1/35 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
E. Sherwood Brown, MD, PhD
University of Texas Southwestern Medical Center
Phone: 2146466948
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place