Clinical trial NCT01040208: 12 Week Safety Trial of Flibanserin in Depressed Women Taking an SSRI or SNRI With Decreased Sexual Desire and Distress
Official title: Safety of Flibanserin Versus Placebo in Women Taking a Selective Serotonin Reuptake Inhibitor or Norepinephrine Serotonin Reuptake Inhibitor With Decreased Sexual Desire
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Sexual Dysfunctions, Psychological
Depression
Lead sponsor: Sprout Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2009-12-29
Enrollment: 111
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period.
timeFrame: 17 weeks
Secondary outcomes:
measure: The Occurrence of Mild Depressive Symptoms (i.e., a Total Score of '7' to '11', Inclusive) That Have Remitted (i.e., a Total Score of '6' or Less) on the 16 Item Quick Inventory of Depressive Symptoms - Self Report at Visit 6 (Week 12)
timeFrame: 12 weeks
measure: The Occurrence of Mild Anxiety Symptoms (i.e., a Total Score of '8' to '16', Inclusive) That Have Remitted (i.e., a Total Score of '7' or Less) on the Beck Anxiety Inventory at Visit 6 (Week 12)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Clinical Innovations
state: California
city: Fresno
country: United States
facility: Mood & Anxiety Research
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: Riverside
country: United States
facility: Clinical Innovations
state: California
city: Sherman Oaks
country: United States
facility: Schuster Medical Research
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Denver
country: United States
facility: Western Affiliated Research Institute
state: Colorado
city: Denver
country: United States
facility: Radiant Research
state: Colorado
city: Altamonte Springs
country: United States
facility: Ali Kashfi
state: Florida
city: Fort Myers
country: United States
facility: Gulf Coast Clinical Research
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Winter Park
country: United States
facility: Kolin Research Group
state: Florida
city: Atlanta
country: United States
facility: Atlanta Institute of Medicine & Research
state: Georgia
city: Atlanta
country: United States
facility: Comprehensive Neuroscience
state: Georgia
city: Chicago
country: United States
facility: Chicago Research Center
state: Illinois
city: Livertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Skokie
country: United States
facility: Psychiatric Medicine Associates
state: Illinois
city: Terre Haute
country: United States
facility: Clinco
state: Indiana
city: Prairie Village
country: United States
facility: Clinical Trials Technology
state: Kansas
city: Baltimore
country: United States
facility: Sheppard Pratt Hospital
state: Maryland
city: Haverhill
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Creve Coeur
country: United States
facility: Millennium Psychiatric Associates
state: Missouri
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience
state: New Mexico
city: Brooklyn
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: Cedarhurst
country: United States
facility: Neurobehavioral Research
state: New York
city: Mount Kisco
country: United States
facility: Bioscience Research
state: New York
city: New York
country: United States
facility: Medical and Behavioral Health Research
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Dayton
country: United States
facility: MIdwest Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: CRI Worldwide
state: Pennsylvania
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions
state: Tennessee
city: Austin
country: United States
facility: Future Search Trials
state: Texas
city: Irving
country: United States
facility: Mary Ann Knesevich
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: San Antonio
country: United States
facility: San Antonio Psychiatric Research Center
state: Texas
city: Richmond
country: United States
facility: Alliance Research Group
state: Virginia
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: