Ginkgo Biloba: Antidepressant-Induced Sexual Dysfunction
Condition: Hypoactive Sexual Desire Disorder; Sexual Dysfunctions, Psychological
MeSH terms: Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to provide the first empirical examination of the effects of
      Ginkgo biloba (GBE), sex therapy, and a combination of the two on subjective and
      physiological measures of sexual function in women who are experiencing sexual disorders
      secondary to antidepressants.
    

Detailed description: 
      Virtually all antidepressant medications are associated with a high incidence of adverse
      sexual side effects. In women, the side effects most commonly reported include decreased
      sexual arousal with decreased lubrication, delayed or inhibited orgasm, and decreased sexual
      desire. To date, there are no effective pharmacological antidotes for treating these sexual
      side effects. Ginkgo biloba extract (GBE), a naturally occurring substance from the ancient
      Chinese Ginkgo tree, has properties proven to increase peripheral blood flow and to
      facilitate the relaxation of smooth muscle tissue. Its effectiveness in this regard has been
      demonstrated in numerous clinical trials that show gingko biloba to be highly efficient in
      treating peripheral vascular disorders. Female sexual arousal involves a complex interplay of
      these very actions - the relaxation of smooth muscle tissue and the inflow of blood to the
      genital region. Hence, pharmacologically, it is feasible that GBE may be effective in
      enhancing female sexual arousal. Moreover, given that the mechanisms hypothesized to
      facilitate female sexual function are operative at a peripheral rather than a central (i.e.,
      neurotransmitter) level, it is unlikely that GBE would adversely impact the mood-alleviating
      therapeutic effects of antidepressant medications that are believed to be centrally mediated.
      Limited, uncontrolled studies lend support to this hypothesis. The purpose of the present
      study is to provide the first empirical examination of the effects of both acute and chronic
      GBE on subjective and physiological measures of sexual function in women who are experiencing
      clinically diagnosable hypoactive sexual desire disorder, female sexual arousal disorder,
      and/or inhibited female orgasm secondary to either to fluoxetine, sertraline, or paroxetine
      use. Women (N = 110) stabilized on antidepressant medication and free of a current Axis I
      disorder will be randomized to 8 weeks of daily treatment with either GBE (200 mg) or
      placebo. Sexual functioning will be assessed through (a) daily patient diary recordings, (b)
      patient-rating scales completed each week, and (c) blind independent evaluator ratings. The
      acute effects of GBE will also be assessed using vaginal photoplethysmograph techniques to
      assess genital blood flow, both prior to and following chronic GBE treatment. The findings
      from the present study will (a) help determine whether chronic and/or acute GBE facilitates
      sexual function in women with antidepressant-induced sexual dysfunction and, (b) examine
      whether acute GBE influences vaginal measures of sexual arousal. If effective, GBE could play
      a significant adjunctive role in the treatment of clinical depression and other psychological
      disorders commonly treated with antidepressant medications.
    

Intervention name(s): Ginkgo Biloba; Sex Therapy (genital focus)
Intervention type(s): Drug; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Female Sexual Arousal Disorder; Female Orgasmic Disorder; ginkgo biloba; human therapy evaluation; sex behavior; antidepressant; blood flow; clinical trial; drug adverse effect; mental disorder chemotherapy; relaxation; smooth muscle; alternative medicine; blood flow measurement; female; placebo; women's health; Secondary to either to fluoxetine, sertraline, or paroxetine use.