12 Week Safety Trial of Flibanserin in Depressed Women Taking an SSRI or SNRI With Decreased Sexual Desire and Distress
Condition: Sexual Dysfunctions, Psychological; Depression
MeSH terms: Sexual Dysfunctions, Psychological
Intervention: flibanserin 50 mg to 100 mg qhs; flibanserin 100 mg qhs; placebo 2 tablets qhs
Intervention description: 50 to 100mg qhs; 100mg qhs; 50 mg placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 111.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      The current trial will explore the safety of flibanserin in combination with Selective
      Serotonin Reuptake Inhibitors or Norepinephrine Serotonin Reuptake Inhibitors in a
      representative population of women with depressive and possible concurrent anxiety
      symptomatology.
    

Eligibility criteria:

        Inclusion criteria:

          1. Women 18-50 years of age, not postmenopausal at the Screen Visit

          2. Women with mild/remitted depressive disorder with score of <11 on the Quick Inventory
             of Depressive Symptoms Self Report and <16 on the Beck Anxiety Inventory at
             Screen/Baseline Visits

          3. Women with decreased sexual desire and distress present at least 4 weeks at Screen
             Visit as determined by the Clinical Interview for Female Sexual Dysfunction-Depression
             and Diagnostic and Statistical Manual IV-Text Revision (DSM IV-TR)

          4. Score of 15 or higher on the Female Sexual Distress Scale-Revised at Screen/Baseline
             Visits

          5. Score of 9 or lower on the Changes in Sexual Functioning Questionnaire-Female
             desire/interest item at Screen/Baseline Visits

          6. Patients must be taking the same Selective Serotonin Reuptake Inhibitor or
             Norepinephrine Serotonin Reuptake Inhibitor for 3 months and be on a stable dose at
             least 2 months before the Screen Visit and remain on this regimen during the trial and
             for 1 month after trial completion

          7. Patients must have had no treatment for Female Sexual Dysfunction 2 months before
             Screen Visit

          8. Patients must use medically accepted contraception method

          9. Patients must be in a secure, stable, monogamous, heterosexual relationship at least
             12 months prior to Screen Visit, according to the Clinical Interview for Female Sexual
             Dysfunction-Depression

        Exclusion criteria:

        Conditions which may interfere with the ability to participate include, but are not limited
        to:

          1. Patients who have taken any Prohibited Medications within 30 days before Baseline
             Visit

          2. Patients with history of drug dependence/abuse (including alcohol) within past year

          3. Patients with history of participation in a trial of another investigational drug
             within 1 month prior to the Screen Visit, or participation in previous flibanserin
             study

          4. Women with lifelong decreased sexual desire (or Hypoactive Sexual Desire Disorder),
             Female Sexual Arousal Disorder and/or Female Orgasmic Disorder, per DSM IV-TR criteria

          5. Patients who meet DSM IV-TR criteria for Sexual Aversion Disorder, Substance-Induced
             Sexual Dysfunction other than Selective Serotonin Reuptake Inhibitor/Norepinephrine
             Serotonin Reuptake Inhibitor-Induced Sexual Dysfunction, Dyspareunia, Vaginismus,
             Gender Identity Disorder, Paraphilia, or Sexual Dysfunction Due to a General Medical
             Condition

          6. Patients who have had a hysterectomy, or are in the post menopause stage (i.e.,
             bilateral oophorectomy, chemically induced menopause)

          7. Patients with history of pelvic inflammatory disease, urinary tract, vaginal
             infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, significant
             vaginal atrophy in the 4 weeks before the Screen Visit

          8. Patients who are breastfeeding or have breastfed within 6 months prior to the Baseline
             Visit.

          9. Patients who are pregnant (by serum pregnancy test) or have been pregnant within 6
             months prior to the Baseline Visit

         10. Patients with current Depressive Disorder (may have concurrent mild Anxiety Disorder)
             not adequately controlled during the last 2 months and/or with a score of <11 on the
             Quick Inventory of Depressive Symptoms Self Report and/or a score of <16 on the Beck
             Anxiety Inventory at Screen and/or Baseline Visits

         11. Patients with history of suicide attempt within the last year or current suicidal
             ideation. Investigator must assess history of suicidality to determine if patient is
             at risk before entering the trial

         12. Patients with history of other psychiatric disorders that could impact sexual
             function, risks patient safety, or may impact compliance. Axis I disorders (except
             anxiety symptoms and disorders) are excluded. Axis II disorders are allowed

         13. Patients with significant cardiac, neurologic, hepatic, renal, hematologic,
             respiratory, gastrointestinal, immunological, endocrine disease

         14. Patients with history of breast cancer or other cancer within the last 5 years, other
             than non-invasive, previously resected skin cancer