Phase 4 N=252 Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder
Premenstrual Dysphoric Disorder
Primary: Premenstrual Tension Scale (PMTS) — 22.3; 21.4; 15.6; 16.8 units on a scale — p=0.21
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 4 N=25 Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder
Premenstrual Syndrome
Primary: Change in Premenstrual Symptoms as Measured by the Premenstrual Tension Scale (PMTS) — -6.9; -5.5; -5.5; -8.3 score on a scale — p== 0.57
Phase 4 N=67 Continuous Oral Contraceptive Treatment in Premenstrual Dysphoric Disorder (PMDD)
Premenstrual Dysphoric Disorder
Primary: Pre-Post Change in Premenstrual Symptom Severity — 1.93; 1.73; 1.64 units on a scale
N/A N=80 Premenstrual Dysphoric Disorder and Antiepileptic Drugs
Epilepsy
Primary: To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies. — 0; 0; 0; 2 Participants
N/A N=32 The Oral Contraceptive Pill for Premenstrual Worsening of Depression
Premenstrual Syndrome · Depression
Primary: Percent Change in Luteal Montgomery-Asberg Depression Rating Scale (MADRS) — -43.6; -38.9 percent change — p=.59
Phase 4 N=84 Stress & Premenstrual Symptoms Study
PMDD · Stress · Mood
Primary: Acoustic Startle Response (ASR) Magnitude Based on Menstrual Cycle Phase — 54.2; 53.7; 56.4; 53.3 t score — p=0.139
N/A N=129 Premenstrual Hormonal and Affective State Evaluation (PHASE) Project
Premenstrual Dysphoric Disorder
Primary: Hormone Analysis — 70.7; 57.8; 114; 97.3 ng/mL
Phase 3 N=10 Emotional Processing and Oxytocin Mechanisms in Premenstrual Dysphoric Disorder: A Pilot Study
Premenstrual Dysphoric Disorder
Primary: Change in Premenstrual Symptom Severity — 25.05; 27.36 units on a scale
Phase 1 N=20 A Treatment Study for Premenstrual Syndrome (PMS)
Premenstrual Syndrome · Menstruation Disturbances
Primary: Mean Beck Depression Inventory Score — 2.6; 3.0; 5.3; 3.6 score on a scale
Phase 4 N=45 The Role of GABA and Neurosteroids in Premenstrual Dysphoric Disorder
Premenstrual Dysphoric Disorder · Premenstrual Syndrome
Primary: Change in Cortical Gama-aminobutyric Acid Levels (GABA Levels) Pre and Post SSRI Treatment
Phase 4 N=46 Unique Effects of Perimenstrual Estradiol or Progesterone Supplementation on Perimenstrual Suicidality
Suicidal Ideation
Primary: Cyclical Change in Suicidal Ideation (SI) Severity — -.22; -.05; .25 units on a scale — p=.002
Phase 4 N=30 Effect of Perimenstrual Ovarian Steroid Supplementation on Perimenstrual Suicidality
Suicidal Ideation
Primary: Perimenstrual Change in Self-Injurious Thoughts and Behaviors Interview (SITBI) Suicidal Ideation Score — -.05; .35 units on a scale — p=.012
N/A N=49 Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)
Premenstrual Syndrome
Primary: Comparison of the Change in IDS Symptom Scores Among Groups — 31.85; 30.92; 28.85; 14.08 units on IDS scale — p=0.07
N/A N=205 Depression Attention for Women Now (The DAWN Study)
Depressive Disorder
Primary: Depression Treatment Outcome — 0.96; 1.33 units on a scale
Phase 4 N=439 Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364)
Major Depressive Disorder
Primary: Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8 — 22.8; 22.4; -9.7; -7.4 Units on a scale — p=0.004
N/A N=36 Neurophysiology of Postpartum Depression in an Experimental Model of Pregnancy and Parturition
Postpartum Depression
Primary: Blood-oxygen-level-dependent (BOLD) Response During Functional Magnetic Resonance Imaging (fMRI) z Statistic — 2.3; 2.0; 2.1; 1.7 z score — p=.27
Phase 2 N=73 A Neurosteroid Intervention for Menopausal and Perimenopausal Depression
Major Depressive Disorder · Menopause · Perimenopause
Primary: Montgomery-Asberg Depression Rating Scale (MADRS) — 26.2; 27.0; 15.7; 15.2 units on a scale — p=0.29
Phase 3 N=381 Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women
Depression · Depressive Disorder · Depressive Disorder, Major
Primary: Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8. — -12.64; -8.33 units on scale — p=<0.001
Phase 2 N=102 Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause
Hot Flashes
Primary: Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 8 — 82.44; 83.18; 37.3; 28.5 Hot flashes — p=0.0177
Phase 4 N=47 Vortioxetine for Menopausal Depression
Depression · Menopause · Vasomotor Disturbance
Primary: Change From Baseline in Montgomery-Asberg Depression Rating Scale Score (MADRS) at Week 8 (Visit 5) — -22.8 units on a scale
Phase 2 N=15 The Role of Hormones in Postpartum Mood Disorders
Postpartum Depression
Primary: Edinburgh Postnatal Depression Scale (EPDS) Mean Total Score — 3.75; 3; 0; 1.14 Units on a scale
N/A N=24 Omega-3 for Peri- and Postmenopausal Depression
Depression
Primary: Change in MADRS Score — 12.0 units on a scale
N/A N=8 Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women
Healthy
Primary: To Determine the Impact of GABA-A Receptor Agonists (Benzodiazepines, Allopregnanolone) and Other GABA-modulating Agents (Fluoxetine) on Cortical GABA Levels by…
Phase 3 N=570 24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms
Hot Flashes
Primary: Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 12. — 10.83; 10.90; -4.13; -2.71 Hot flashes per day — p=<0.0001
Phase 4 N=34 Estrogen Variability and Irritability During the Menopause Transition
Menopause · Irritable Mood
Primary: Mean IDAS Ill Temper Scale Score Over Time — 6.19; 6.02 score on a scale — p=0.09
Phase 2 N=23 Pioglitazone for the Treatment of Major Depressive Disorder Comorbid With Metabolic Syndrome
Depressive Disorder, Major · Metabolic Syndrome X
Primary: Change in Depression Symptom Severity From Baseline to Study Endpoint — -20.9 Units on a scale
N/A N=500 Preventing Depressive Relapse in Pregnant Women With Recurrent Depression
Depression · Pregnancy Related · Antenatal Depression
Primary: Number of Participants Experiencing Relapse of Depression — 81; 111 Participants
Phase 4 N=63 Raloxifene and Rimostil for Perimenopause-Related Depression
Perimenopausal Depression · Depression
Primary: Center for Epidemiologic Studies-Depression Scale (CES-D) — 27.4; 29.1; 28.8; 24.6 Units on a scale
Phase 2 N=4 Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression
Postpartum Depression
Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) — 4; 0 Participants
Phase 3 N=48 Major Depressive Disorder With Mixed Features - Extension
Major Depressive Disorder
Primary: Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) — 66.7 percentage of subjects