Phase 4 Completed N=80 Randomized Triple-blind Treatment

Study Using Pregnenolone to Treat Bipolar Depression

Bipolar Disorder · Major Depressive Disorder

Source: ClinicalTrials.gov NCT01409096 ↗

Enrolled (actual)

Serious AEs

9.6%

Results posted

Mar 2016

Primary outcomePrimary: The 17-item Hamilton Rating Scale for Depression (HRSD17) — 9.18; 9.41 units on a scale — p=0.9084

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

Primary purpose of this study is to determine if pregnenolone supplementation is associated with greater improvement in depressive symptoms of patients with bipolar disorder. Also the study will explore possibilities of improving anxiety and manic symptoms as well as the patient's cognition.

Outcome Measures

Outcome	Result	p-value
PRIMARY The 17-item Hamilton Rating Scale for Depression (HRSD17)	9.18; 9.41	0.9084
SECONDARY Inventory of Depressive Symptomatology-Self Report (IDS-SR)	15.78; 18.23	0.5187
SECONDARY Young Mania Rating Scale (YMRS)	5.84; 6.63	0.6060
SECONDARY Hamilton Rating Scale for Anxiety (HRSA)	8.80; 10.32	0.5110

Eligibility Criteria

Inclusion Criteria

Men and Women of all races age 18-75 years
Diagnosis of bipolar I, II or not otherwise specified (NOS) disorders currently meeting criteria for a major depressive episode
English speaking

Exclusion Criteria

Active suicidal ideation with plan and intent
Treatment resistant depression
Vulnerable population (i.e. pregnant, cognitively impaired, incarcerated)
Severe or life threatening medical condition
History of allergic reaction or side effects with prior pregnenolone use
Current substance use disorder defined as meeting criteria for abuse or dependence based on the Structured Clinical Interview for the Diagnostic and Statistical Manual (DSM)(SCID) interview and self-reported use within the past 3 months or a positive baseline urine drug screen
Removal or addition of concomitant psychiatric medications within 10 days prior to randomization
Current Warfarin therapy
Current use of oral contraceptives
Current hormone replacement therapy
History of heart disease or arrhythmias
Current (past 7 days) systemic

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01409096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.