Depression Clinical Trial
Official title:
Safety of Flibanserin Versus Placebo in Women Taking a Selective Serotonin Reuptake Inhibitor or Norepinephrine Serotonin Reuptake Inhibitor With Decreased Sexual Desire
NCT number | NCT01040208 |
Other study ID # | 511.114 |
Secondary ID | |
Status | Terminated |
Phase | Phase 3 |
First received | December 28, 2009 |
Last updated | March 2, 2012 |
Start date | January 2010 |
Verified date | March 2012 |
Source | Sprout Pharmaceuticals, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 111 |
Est. completion date | |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion criteria: 1. Women who are 18 to 50 years of age and not post-menopausal (i.e., 12 consecutive months of amenorrhea) at the Screen Visit. 2. Women with mild or remitted depressive disorder (may also have concurrent mild anxiety disorder or premenstrual dysphoric disorder) supported by a score of <'11' on the Quick Inventory of Depressive Symptoms Self Report 16 and <'16' on the Beck Anxiety Inventory at Screen and Baseline Visits. 3. Women must have decreased sexual desire and distress that has been present for at least four weeks at Screen Visit as determined by the Clinical Interview for Female Sexual Dysfunction - Depression and Diagnostic and Statistical Manual IV-Text Revision criteria. 4. A score of '15' or higher on the Female Sexual Distress Scale-Revised at the Screen and Baseline Visits. 5. A score of '9' or lower on the Changes in Sexual Functioning Questionnaire-Female desire/interest item at the Screen and Baseline Visits. 6. Patients must be taking the same Selective Serotonin Reuptake Inhibitor or Norepinephrine Serotonin Reuptake Inhibitor for three months and be on a stable dose for at least two months before the Screen Visit and plan to remain on this same Selective Serotonin Reuptake Inhibitor or Norepinephrine Serotonin Reuptake Inhibitor through out the trial and for one month after the completion of the trial. 7. Patients must have had no treatment for Female Sexual Dysfunction in the two months before the start of the Screen Visit. 8. Patients must use a medically acceptable method of contraception. 9. Patients must be in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least twelve months prior to the Screen Visit, according to the Clinical Interview for Female Sexual Dysfunction - Depression. The relationship is to be with the same partner who is sexually functional, both psychologically and physically, and the partner is expected to be physically present. Exclusion criteria: Clinically relevant conditions which might interfere with the patient's ability to participate in the trial include, but are not limited to the following: 1. Patients who have taken any Prohibited Medications, within 30 days before the Baseline Visit. 2. Patients with a history of drug dependence or abuse (including alcohol, as defined in Diagnostic and Statistical Manual IV-Text Revision or in the opinion of the investigator) within the past 12 months. 3. Patients with a history of participation in a trial of another investigational medication within one month prior to the Screen Visit, or participation in any previous clinical trial of flibanserin. 4. Women with lifelong: decreased sexual desire (or Hypoactive Sexual Desire Disorder), Female Sexual Arousal Disorder and/or Female Orgasmic Disorder, according to Diagnostic and Statistical Manual IV-Text Revision criteria. 5. Patients who meet Diagnostic and Statistical Manual IV-Text Revision criteria for Sexual Aversion Disorder, Substance-Induced Sexual Dysfunction other than Selective Serotonin Reuptake Inhibitor or Norepinephrine Serotonin Reuptake Inhibitor-Induced Sexual Dysfunction, Dyspareunia (not caused by inadequate foreplay stimulation or alleviated by lubricants), Vaginismus, Gender Identity Disorder, Paraphilia, or for Sexual Dysfunction Due to a General Medical Condition other than Sexual Dysfunction Due to Depression. 6. Patients who have had a hysterectomy (with or without bilateral oophorectomy), or are in the post menopause stage (i.e., had bilateral oophorectomy or have chemical induced [e.g., chemotherapy] menopause). 7. Patients with a history of pelvic inflammatory disease, urinary tract or vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy in the preceding four weeks before the Screen Visit. 8. Patients who are breastfeeding or have breastfed within the six months prior to the Baseline Visit. 9. Patients who are pregnant (by serum pregnancy test at the Screen Visit) or have been pregnant within the six months prior to the Baseline Visit. 10. Patients with a current episode of Depressive Disorder (may also have concurrent mild Anxiety Disorder) not adequately controlled during the last two months and/or with a score of <11 on the Quick Inventory of Depressive Symptoms Self Report 16 and/or a score of <16 on the Beck Anxiety Inventory at Screen and/or Baseline Visits. 11. Patients with a history of suicide attempt within the last 12 months or currently active suicidal ideation. The investigator must assess the patient's history of suicide attempt/ideation and determine if the patient is "at risk" before entering the trial. 12. Patients with a history of any other psychiatric disorders that could impact sexual function, risks patient's safety, or may impact compliance. Axis I disorders (except anxiety symptoms and disorders) including eating disorders are excluded. Axis II disorders (except mental retardation and anti-social personality disorder) are allowed. 13. Patients with clinically significant cardiac, neurologic, hepatic, renal, hematologic, respiratory, gastrointestinal, immunological, and endocrine disease. 14. Patients with a history of breast cancer and/or other cancer within the last 5 years, other than non-invasive, previously resected skin cancer. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | 511.114.01011 Boehringer Ingelheim Investigational Site | Albuquerque | New Mexico |
United States | 511.114.01029 Boehringer Ingelheim Investigational Site | Altamonte Springs | Florida |
United States | 511.114.01005 Boehringer Ingelheim Investigational Site | Atlanta | Georgia |
United States | 511.114.01036 Boehringer Ingelheim Investigational Site | Atlanta | Georgia |
United States | 511.114.01019 Boehringer Ingelheim Investigational Site | Austin | Texas |
United States | 511.114.01012 Boehringer Ingelheim Investigational Site | Baltimore | Maryland |
United States | 511.114.01045 Boehringer Ingelheim Investigational Site | Brooklyn | New York |
United States | 511.114.01006 Boehringer Ingelheim Investigational Site | Cedarhurst | New York |
United States | 511.114.01032 Boehringer Ingelheim Investigational Site | Chicago | Illinois |
United States | 511.114.01001 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio |
United States | 511.114.01061 Boehringer Ingelheim Investigational Site | Costa Mesa | California |
United States | 511.114.01048 Boehringer Ingelheim Investigational Site | Creve Coeur | Missouri |
United States | 511.114.01009 Boehringer Ingelheim Investigational Site | Dayton | Ohio |
United States | 511.114.01015 Boehringer Ingelheim Investigational Site | Denver | Colorado |
United States | 511.114.01034 Boehringer Ingelheim Investigational Site | Denver | Colorado |
United States | 511.114.01033 Boehringer Ingelheim Investigational Site | Fort Myers | Florida |
United States | 511.114.01046 Boehringer Ingelheim Investigational Site | Fresno | California |
United States | 511.114.01027 Boehringer Ingelheim Investigational Site | Gainesville | Florida |
United States | 511.114.01060 Boehringer Ingelheim Investigational Site | Haver Hill | Massachusetts |
United States | 511.114.01043 Boehringer Ingelheim Investigational Site | Irving | Texas |
United States | 511.114.01028 Boehringer Ingelheim Investigational Site | Jacksonville | Florida |
United States | 511.114.01022 Boehringer Ingelheim Investigational Site | Livertyville | Illinois |
United States | 511.114.01026 Boehringer Ingelheim Investigational Site | Media | Pennsylvania |
United States | 511.114.01002 Boehringer Ingelheim Investigational Site | Memphis | Tennessee |
United States | 511.114.01052 Boehringer Ingelheim Investigational Site | Mount Kisco | New York |
United States | 511.114.01003 Boehringer Ingelheim Investigational Site | National City | California |
United States | 511.114.01021 Boehringer Ingelheim Investigational Site | New York | New York |
United States | 511.114.01041 Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma |
United States | 511.114.01024 Boehringer Ingelheim Investigational Site | Orlando | Florida |
United States | 511.114.01023 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania |
United States | 511.114.01040 Boehringer Ingelheim Investigational Site | Prairie Village | Kansas |
United States | 511.114.01051 Boehringer Ingelheim Investigational Site | Richmond | Virginia |
United States | 511.114.01013 Boehringer Ingelheim Investigational Site | Riverside | California |
United States | 511.114.01008 Boehringer Ingelheim Investigational Site | San Antonio | Texas |
United States | 511.114.01031 Boehringer Ingelheim Investigational Site | San Antonio | Texas |
United States | 511.114.01037 Boehringer Ingelheim Investigational Site | Sherman Oaks | California |
United States | 511.114.01042 Boehringer Ingelheim Investigational Site | Skokie | Illinois |
United States | 511.114.01039 Boehringer Ingelheim Investigational Site | Tampa | Florida |
United States | 511.114.01025 Boehringer Ingelheim Investigational Site | Terre Haute | Indiana |
United States | 511.114.01057 Boehringer Ingelheim Investigational Site | Toms River | New Jersey |
United States | 511.114.01049 Boehringer Ingelheim Investigational Site | Walnut Creek | California |
United States | 511.114.01030 Boehringer Ingelheim Investigational Site | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
Sprout Pharmaceuticals, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary safety endpoint is the occurrence of adverse events during the treatment and post treatment period. | 17 weeks | Yes | |
Secondary | 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) | 12 weeks | Yes | |
Secondary | 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) | 12 weeks | Yes | |
Secondary | Change from baseline on blood pressure and pulse, weight. | 12 weeks | Yes | |
Secondary | .Change from baseline on laboratory and electrocardiogram values. | 12 weeks | Yes | |
Secondary | Change from baseline on mean score for the 16 Item Quick Inventory of Depressive Symptoms - Self Report. | 12 weeks | Yes | |
Secondary | Change from baseline on mean score of Beck Anxiety Inventory. | 12 weeks | Yes | |
Secondary | The occurrence of suicidal behavior or ideation as a change from baseline on the Columbia-Suicide Severity Rating Scale. | 12 weeks | Yes |
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