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Completed

NCT Number: NCT01409096

Study Using Pregnenolone to Treat Bipolar Depression

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Depressive Disorder, Major Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75235, United States

About this study

Determine if pregnenolone supplementation is associated with greater improvement in depressive symptoms than placebo in persons with Bipolar Depression (BPD), depressed phase. In our pilot study, pregnenolone showed a strong signal on depression scores.

Secondary

  • Determine if pregnenolone supplementation is associated with greater improvement in anxiety symptoms in persons with BPD, depressed phase. Data from prior studies suggests that pregnenolone may decrease symptoms of anxiety. Anxiety is a common and clinically important feature of BPD. Therefore, we will examine anxiety symptoms in this trial.
  • Determine if pregnenolone supplementation is associated with improvement in manic symptoms as compared to placebo in persons with BPD, depressed phase. Our pilot study suggested that pregnenolone may be associated with improvement in manic symptoms. Although the current study targets bipolar depression we will also examine manic symptoms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregnenolone

Drug

Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system.

Other names: 3β-hydroxypregn-5-en-20-one

Placebo

Drug

Inactive ingredient matching the active medication in appearance.

Other names: Sugar pill

Primary outcomes

  1. The 17-item Hamilton Rating Scale for Depression (HRSD17)

    Time frame: 12 weeks

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

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

Secondary outcomes

  1. Inventory of Depressive Symptomatology-Self Report (IDS-SR)

    Time frame: 12 weeks

    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

  2. Young Mania Rating Scale (YMRS)

    Time frame: 12 weeks

    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

  3. Hamilton Rating Scale for Anxiety (HRSA)

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • Stanley Medical Research Institute

Registry information

Official study title

A Randomized, Double Blind, Placebo-controlled Trial of Pregnenolone for Bipolar Depression

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 3, 2011
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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