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Study Using Pregnenolone to Treat Bipolar Depression

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ClinicalTrials.gov Identifier: NCT01409096
Recruitment Status : Completed
First Posted : August 3, 2011
Results First Posted : March 31, 2016
Last Update Posted : March 31, 2016
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Sherwood Brown, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Bipolar Disorder
Major Depressive Disorder
Interventions Drug: Pregnenolone
Drug: Placebo
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pregnenolone Placebo
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 40 40
Completed 38 35
Not Completed 2 5
Arm/Group Title Pregnenolone Placebo Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 38 35 73
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 35 participants 73 participants
43.2  (8.5) 44.1  (10.4) 43.6  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 35 participants 73 participants
Female
16
  42.1%
24
  68.6%
40
  54.8%
Male
22
  57.9%
11
  31.4%
33
  45.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants 35 participants 73 participants
African-American 18 15 33
Caucasian 18 16 34
Hispanic 2 4 6
Bipolar Diagnosis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants 35 participants 73 participants
Bipolar I 16 15 31
Bipolar II 21 17 38
Bipolar Not Otherwise Specified 1 3 4
[1]
Measure Description: Participants were graded clinically by using the Diagnostic and Statistical Manual of Mental Disorders (DSM) guidelines for criteria from a structured clinical interview.
Age of onset of mood symptoms  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 35 participants 73 participants
26.4  (9.0) 26.7  (7.3) 26.7  (8.22)
Concomitant Medications: Lithium  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants 35 participants 73 participants
Lithium 5 4 9
No Lithium 33 31 64
Concomitant Medications: Anticonvulsant  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants 35 participants 73 participants
Anticonvulsants 10 10 20
No anticonvulsants 28 25 53
Concomitant Medications: Antidepressant  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants 35 participants 73 participants
Antidepressants 21 22 43
No antidepressants 17 13 30
Concomitant Medications: Antipsychotic  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants 35 participants 73 participants
Antipsychotic 17 18 35
No antipsychotic 21 17 38
Concomitant Medications: Sedative/hypnotic/anxiolytic  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants 35 participants 73 participants
Sedative/hypnotic/anxiolytic 16 20 36
No Sedative/hypnotic/anxiolytic 22 15 37
Concomitant medications: Stimulant  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants 35 participants 73 participants
Stimulant 0 1 1
No stimulant 38 34 72
Concomitant medications: None  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants 35 participants 73 participants
No concomitant medications 7 6 13
Concomitant medication 31 29 60
Hamilton Rating Scale for Depression (HRSD)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 38 participants 35 participants 73 participants
21.3  (4.0) 23.5  (4.6) 22.4  (4.3)
[1]
Measure Description: Minimum: 0 Maximum: 50 Better outcome: lower Normal= 7 or less
Inventory of Depressive Symtomatology-Self Report (IDS-SR)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 38 participants 35 participants 73 participants
38.0  (14.5) 47.5  (14.5) 42.7  (15.2)
[1]
Measure Description: Minimum: 0 Maximum: 84 Better outcome: Lower Normal: 7 or less
Young Mania Rating Scale (YMRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 38 participants 35 participants 73 participants
10.1  (4.7) 10.4  (4.3) 10.1  (4.3)
[1]
Measure Description: Minimum: 0 Maximum: 60 Better outcome: lower
Hamilton Rating Scale for Anxiety (HRSA)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 38 participants 35 participants 73 participants
19.4  (9.8) 22.8  (8.1) 21.1  (9.2)
[1]
Measure Description: Minimum: 0 Maximum: 56 Better outcome: lower
1.Primary Outcome
Title The 17-item Hamilton Rating Scale for Depression (HRSD17)
Hide Description

The HRSD is an observer-rated measure of depressive symptomatology.

Minimum: 0; Maximum: 50; Better outcome: lower score; Normal score: 7 or less.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregnenolone Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 38 35
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
9.18  (1.41) 9.41  (1.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregnenolone, Placebo
Comments Baseline HRSD scores used as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9084
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Inventory of Depressive Symptomatology-Self Report (IDS-SR)
Hide Description

IDS-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

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregnenolone Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 38 35
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
15.78  (2.64) 18.23  (2.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregnenolone, Placebo
Comments Baseline IDS-SR used as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5187
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Young Mania Rating Scale (YMRS)
Hide Description

This 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

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregnenolone Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 38 35
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
5.84  (1.09) 6.63  (1.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregnenolone, Placebo
Comments Baseline YMRS used as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6060
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Hamilton Rating Scale for Anxiety (HRSA)
Hide Description

The 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.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregnenolone Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 38 35
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
8.80  (1.63) 10.32  (1.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregnenolone, Placebo
Comments Baseline HRSA used as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5110
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pregnenolone Placebo
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Pregnenolone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pregnenolone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/38 (10.53%)      3/35 (8.57%)    
Eye disorders     
Corneal ulceration *  1/38 (2.63%)  1 0/35 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis *  0/38 (0.00%)  0 1/35 (2.86%)  1
Injury, poisoning and procedural complications     
Injuries secondary to motor vehicle accident *  0/38 (0.00%)  0 1/35 (2.86%)  1
Fall *  0/38 (0.00%)  0 1/35 (2.86%)  1
Respiratory, thoracic and mediastinal disorders     
Sinusitis *  1/38 (2.63%)  1 0/35 (0.00%)  0
Skin and subcutaneous tissue disorders     
Skin abscess followed by allergic reaction to antibiotic used to treat it *  1/38 (2.63%)  1 0/35 (0.00%)  0
Skin rash *  1/38 (2.63%)  1 0/35 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pregnenolone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/38 (0.00%)      0/35 (0.00%)    
Sample size; treatment groups not well matched on gender or depressive symptom scores
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: E. Sherwood Brown, MD, PhD
Organization: University of Texas Southwestern Medical Center
Phone: 2146466948
Responsible Party: Sherwood Brown, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01409096     History of Changes
Other Study ID Numbers: 122009-069
First Submitted: August 2, 2011
First Posted: August 3, 2011
Results First Submitted: January 6, 2016
Results First Posted: March 31, 2016
Last Update Posted: March 31, 2016