[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07734701":3,"trial-entities:NCT07734701":131,"trial-summary:NCT07734701":136},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":45,"secondary_outcomes":50,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":85,"locations":87,"central_contacts":118,"overall_officials":121,"references":122,"see_also_links":130},"NCT07734701","STU20261165","Pregnenolone Treatment for Alcohol Use Disorder and Major Depressive Disorder","Targeting Neurosteroid Pathways in Alcohol Use Disorder: Clinical and Neural Impact of Pregnenolone Therapy","NOT_YET_RECRUITING","2031-03","2026-07","2026-07-29","2026-10","Sherwood Brown, MD, PhD","OTHER",true,"This study will evaluate whether pregnenolone is an effective treatment for adults with Alcohol Use Disorder (AUD) and Major Depressive Disorder (MDD). Participants will be randomly assigned to receive either pregnenolone or placebo for 12 weeks in a double-blind study. Researchers will assess alcohol consumption, alcohol craving, depressive symptoms, and anxiety symptoms throughout treatment. The study will also use magnetic resonance imaging (MRI) to examine how pregnenolone affects brain circuits involved in addiction and mood regulation. The goal is to determine whether pregnenolone can improve both alcohol-related and mood-related outcomes and to identify the neural mechanisms associated with treatment response.","Alcohol Use Disorder (AUD) commonly co-occurs with Major Depressive Disorder (MDD), resulting in substantial morbidity and limited treatment success. Pregnenolone is an endogenous neurosteroid that has demonstrated potential therapeutic effects on alcohol use, craving, mood symptoms, and neural pathways implicated in addiction and depression.\n\nThis randomized, double-blind, placebo-controlled trial will enroll approximately 100 adults aged 21 to 55 years with DSM-5 diagnoses of AUD and MDD. Participants will be randomized to receive pregnenolone 500 mg\u002Fday (250 mg twice daily) or matched placebo for 12 weeks.\n\nThe primary objective is to determine whether pregnenolone reduces alcohol consumption compared with placebo. Secondary clinical objectives include evaluating effects on alcohol craving, depressive symptom severity, and anxiety symptoms. Mechanistic objectives include examining the effects of pregnenolone on resting-state functional connectivity between the amygdala and prefrontal cortex and on brain responses to alcohol-related cues using functional magnetic resonance imaging (fMRI).\n\nClinical assessments will be conducted throughout the treatment period, and MRI scans will be obtained at baseline and Week 12. Relationships between neuroimaging measures and clinical outcomes will also be evaluated. Findings from this study may support the development of a novel treatment approach for individuals with co-occurring AUD and MDD.",[19,20],"Alcohol Use Disorder (AUD)","Major Depressive Disorder (MDD)",[22,23,24,25,26,27,28],"Pregnenolone","Alcohol Use Disorder","Major Depressive Disorder","Neurosteroids","fMRI","Anxiety","Substance Use Disorders","INTERVENTIONAL","TREATMENT",[32],"PHASE2",{"count":34,"type":35},100,"ESTIMATED",[37,41],{"type":38,"name":22,"description":39,"armGroupLabels":40},"DRUG","Pregnenolone 500 mg\u002Fday administered as 250 mg twice daily for 12 weeks.",[22],{"type":38,"name":42,"description":43,"armGroupLabels":44},"Placebo","Matching placebo capsules administered twice daily for 12 weeks.",[42],[46],{"measure":47,"description":48,"timeFrame":49},"Alcohol Consumption","Change in alcohol consumption from baseline to Week 12.\n\nThe timeline follow-back (TLFB) is a semi-structured interview method assessing recent drinking in which participants retrospectively estimate daily quantity of alcohol consumption during specified time periods. The TLFB will be used to assess alcohol use including drinks\u002Fdrinking day and drinks\u002Fday (7-day average).","Baseline to Week 12",[51,54,57,60],{"measure":52,"description":53,"timeFrame":49},"Alcohol Craving","Change in alcohol craving severity from baseline to Week 12.\n\nThe PACS is a 5-item, self-report measure that includes questions about the frequency, intensity and duration of alcohol craving in the previous week. PACS will be used to measure alcohol craving.",{"measure":55,"description":56,"timeFrame":49},"Depressive Symptom Severity","Change in depressive symptom severity from baseline to Week 12.\n\nThe Quick Inventory of Depressive Symptomatology Clinician version (QIDS-C) is a 16-item observer-rated scale assessing depressive symptom severity. The QIDS-C will be used to measure changes in depressive symptom severity.",{"measure":58,"description":59,"timeFrame":49},"Anxiety Symptom Severity","Change in anxiety symptom severity from baseline to Week 12.\n\nThe Hamilton Anxiety Rating Scale (HAM-A) is a 14-item, observer-rated scale assessing anxiety symptom severity. The HAM-A will be used to measure changes in anxiety symptom severity.",{"measure":61,"description":62,"timeFrame":63},"Amygdala-Prefrontal Functional Connectivity","Change in resting-state functional connectivity between the amygdala and prefrontal cortex.\n\nResting-state functional connectivity (rsFC) will be measured. Each participant's average connectivity between prefrontal cortex and amygdala regions of interest (ROIs) will be calculated by averaging the Fisher's Z-transformed pairwise correlation coefficients among the selected ROI pairs.","Baseline and Week 12","ALL","21 Years","55 Years",false,{"inclusion":69,"exclusion":75,"raw_text":84},[70,71,72,73,74],"Age 21 to 55 years.","Meets DSM-5 criteria for Alcohol Use Disorder (AUD).","Meets DSM-5 criteria for Major Depressive Disorder (MDD).","Able to provide informed consent.","Willing and able to comply with study procedures and assessments",[76,77,78,79,80,81,82,83],"Current diagnosis of bipolar disorder, schizophrenia spectrum disorder, or other psychotic disorder.","Current substance use disorder requiring immediate treatment other than alcohol or nicotine.","Significant unstable medical or neurologic illness that would interfere with participation or study assessments.","Contraindications to magnetic resonance imaging (MRI).","Current pregnancy or breastfeeding.","Current use of medications or treatments that would interfere with study participation or interpretation of results.","Significant suicide risk requiring a higher level of care.","Any condition that, in the investigator's judgment, would make participation unsafe or compromise study integrity.","Inclusion Criteria:\n\n* Age 21 to 55 years.\n* Meets DSM-5 criteria for Alcohol Use Disorder (AUD).\n* Meets DSM-5 criteria for Major Depressive Disorder (MDD).\n* Able to provide informed consent.\n* Willing and able to comply with study procedures and assessments\n\nExclusion Criteria:\n\n* Current diagnosis of bipolar disorder, schizophrenia spectrum disorder, or other psychotic disorder.\n* Current substance use disorder requiring immediate treatment other than alcohol or nicotine.\n* Significant unstable medical or neurologic illness that would interfere with participation or study assessments.\n* Contraindications to magnetic resonance imaging (MRI).\n* Current pregnancy or breastfeeding.\n* Current use of medications or treatments that would interfere with study participation or interpretation of results.\n* Significant suicide risk requiring a higher level of care.\n* Any condition that, in the investigator's judgment, would make participation unsafe or compromise study integrity.",[86],"ADULT",[88,105],{"facility":89,"city":90,"state":91,"zip":92,"country":93,"contacts":94,"geoPoint":102},"UT Southwestern Medical Center","Dallas","Texas","75390","United States",[95,100],{"name":96,"role":97,"phone":98,"email":99},"E. Sherwood Brown","CONTACT","214-645-6950","SHERWOOD.BROWN@UTSouthwestern.edu",{"name":96,"role":101},"PRINCIPAL_INVESTIGATOR",{"lat":103,"lon":104},32.78306,-96.80667,{"facility":106,"city":107,"state":91,"zip":108,"country":93,"contacts":109,"geoPoint":115},"University of Texas at Dallas","Richardson","75080",[110,114],{"name":111,"role":97,"phone":112,"email":113},"Francesca Filbey","972-883-2313","francesca.filbey@utdallas.edu",{"name":111,"role":101},{"lat":116,"lon":117},32.94818,-96.72972,[119,120],{"name":96,"role":97,"phone":98,"email":99},{"name":111,"role":97,"phone":112,"email":113},[],[123,127],{"pmid":124,"type":125,"citation":126},"24917198","BACKGROUND","Brown ES, Park J, Marx CE, Hynan LS, Gardner C, Davila D, Nakamura A, Sunderajan P, Lo A, Holmes T. A randomized, double-blind, placebo-controlled trial of pregnenolone for bipolar depression. Neuropsychopharmacology. 2014 Nov;39(12):2867-73. doi: 10.1038\u002Fnpp.2014.138. Epub 2014 Jun 11.",{"pmid":128,"type":125,"citation":129},"29045302","Mason BL, Van Enkevort E, Filbey F, Marx CE, Park J, Nakamura A, Sunderajan P, Brown ES. Neurosteroid Levels in Patients With Bipolar Disorder and a History of Cannabis Use Disorders. J Clin Psychopharmacol. 2017 Dec;37(6):684-688. doi: 10.1097\u002FJCP.0000000000000793.",[],{"nct_id":4,"conditions":132,"biomarkers":135},[133,134],"Alcohol use disorder","Unipolar Depression",[],{"nct_id":4,"found":15,"summary":137,"prompt_version":147},{"design":138,"status":139,"heading":140,"summary":141,"follow_up":142,"word_count":143,"commitments":144,"compensation":145,"drugs_mentioned":146},"This is a randomized, double-blind, placebo-controlled study, meaning you would be randomly assigned to pregnenolone or placebo, and neither you nor the researchers would know which you are receiving. It plans to enroll about 100 adults.","completed","Pregnenolone for Alcohol Use Disorder and Major Depressive Disorder","This study is testing if pregnenolone (a natural steroid) can help adults who have both Alcohol Use Disorder (AUD) and Major Depressive Disorder (MDD). You would be randomly assigned to receive either pregnenolone (500 mg\u002Fday) or a placebo (an inactive pill) for 12 weeks. Researchers will look at how much alcohol you drink, your cravings, and your depression and anxiety symptoms. They will also use MRI scans to see how pregnenolone affects brain areas linked to addiction and mood. The goal is to see if pregnenolone can improve both alcohol use and mood, and how it works in the brain. The study plans to enroll about 100 participants, but its current status is unclear.","The primary endpoint for measuring alcohol consumption is at Week 12, which is the end of the treatment period.",114,"You would take pregnenolone or placebo twice daily for 12 weeks. Clinical assessments would be done throughout this period, and MRI scans would be taken at the beginning and end of the 12 weeks.","Not stated in the trial record.",[22,42],"v2"]