Antidepressant Induced Sexual Dysfunction
Conditions
Keywords
Antidepressant Induced Sexual Dysfunction, Depression, Sexual Dysfunction
Brief summary
The purpose of this study is to find out whether Maca Root is effective for treating sexual dysfunction in females that is caused by antidepressant drugs. An additional aim of the study is to document the safety and tolerability of maca root, as well as any potential side effects that it causes.
Detailed description
This is a 12-week, double-blind, placebo-controlled trial comparing maca root (3.0 g/day) versus an inactive placebo in female outpatients with SSRI/SNRI-induced sexual dysfunction whose depression had remitted with SSRI treatment. Outcome measures include improvement in sexual functioning as per the Arizona Sexual Experience Scale (ASEX) and the Massachusetts General Hospital Sexual Function Questionnaire (MGH-SFQ).
Interventions
DRUGMaca Root
3g/day of Maca Root for 12 weeks.
DRUGPlacebo
Placebo provided by research pharmacy daily for 12 weeks.
Sponsors
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
A Healthy Alternative, LLC
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Study subjects and investigator clinicians were blinded to the treatment assignment.
Intervention model description
Subjects were randomized in a double blind manner to maca root or placebo. Improvement in sexual functioning was compared between the two treatment groups.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject is female, age 18 to 80 years * Subject has been taking an SSRI, venlafaxine, or tri/heterocyclic antidepressant for the treatment of depression for at least 8 weeks; and is currently on a stable dose of the antidepressant for at least 4 weeks * Subject is currently euthymic (HAM-D \< 10) and is without significant anxiety symptoms (HAM-A \< 10) * Subject must have had no sexual dysfunction prior to taking antidepressant and there must be a clear temporal relationship between the sexual dysfunction and the antidepressant treatment * Subject must have been consistently experiencing at least one of the following criteria for at least 4 weeks, with distress or disability: * Inability to have an orgasm, according to patient opinion * Clinically significant orgasm delay with masturbation or intercourse * Inability to attain or maintain until completion of sexual activity an adequate lubrication swelling response of sexual excitement * Decreased libido according to patient opinion * Subject must be having or had been having some form of regular sexual activity (masturbation, oral sex, intercourse) at least twice monthly prior to the antidepressant treatment and are willing to continue efforts at sexual activity at least once weekly for the duration of the study * Subject must be in good general physical health * Subject must be able to understand and communicate in English * Subject must have given informed consent to participate in the study
Exclusion criteria
* Primary or prior diagnosis of a sexual disorder (other than the side effect of the bipolar medication or symptom of the bipolar disorder) * Sexual dysfunction secondary to general underlying medical condition * Penile, vaginal, clitoral or other sexual organ anatomical deformities * Any uncontrolled psychiatric disorder * Alcohol or substance abuse or dependence within the past six months * Recent major relationship changes, disruption, or turmoil ongoing or anticipated which are unrelated to her sexual dysfunction * Hamilton Depression and/or Anxiety Scale score (either) \> 10 * Blood pressure outside the range of 90/50 - 170/100 * Known hyperprolactinemia * Use of investigational drugs within previous 3 months or during study * Current use of other drugs for antidepressant induced sexual dysfunction or other therapies or medications to treat sexual dysfunction * Current use of nefazodone * Hormone replacement therapy, unless patient has been on stable dose of hormone therapy for at least 3 mo prior to the antidepressant treatment and had no sexual dysfunction while on the same hormone therapy regimen, and there is no change in the HRT during the study * Pregnancy, lactating, or planning to become pregnant during the study * Child bearing potential subjects unwilling and/or not prepared and/or who are judged unreliable to use an acceptable and verifiable form of contraception during the study * Any clinically significant abnormality on the screening physical examination * History of hormonal cancers * Any medical or psychological condition or social circumstances that would impair subject's ability to participate reliably in the study, or that may increase the risk to subjects or others as a result of participating in this study * Dyspareunia secondary to an inflammatory or anatomical condition * Prior use of maca for at least two weeks * Infection of the urogenital tract that may make sexual activity painful or difficult * Subjects whose sexual partners are suffering from and/or receiving treatment for sexual dysfunction * Receiving psychosexual or other therapy for sexual dysfunction and not willing to discontinue that treatment at screening * Subjects who do not understand and communicate in English * Subjects for whom sexual activity is inadvisable * Subjects whose sexual dysfunction is considered to be situational * Subjects not attempting some form of regular sexual activity at least twice monthly and at least once weekly during study visit intervals for duration of entire study * Changes in antidepressant agent and/or dose of medication within the last 4 weeks before baseline visit * Participants on medications with a narrow therapeutic window or low therapeutic index for which small variations may be harmful given the lack of systematic experience with drug-supplement interactions (i.e. - cyclosporine, digoxin, warfarin, and antiretrovirals)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants in Remission Based on Arizona Sexual Experience Scale (ASEX) Score of 10 or Less After 12 Weeks of Treatment. | 12 weeks | Arizona Sexual Experience Scale (ASEX) consists of five items rating sexual drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm.The range of total score is 5-30 with the higher scores indicating greater sexual dysfunction. A total final score of 10 or less is considered to indicate remission of sexual dysfunction. |
| Proportion of Participants in Remission Based on Massachusetts General Hospital Sexual Functioning Questionnaire (MGH-SFQ) Score of 12 or Less After 12 Weeks of Treatment. | 12 weeks | Massachusetts General Hospital-Sexual Functioning Questionnaire (MGH-SFQ) is composed of five items evaluating libido, sexual arousal or excitement, ability to achieve orgasm, ability to achieve and maintain an erection (for men only) and overall sexual satisfaction. Items are rated on a scale of 1 to 6 with a rating of 1 indicating greater than normal functioning and a rating of 6 indicating totally absent functioning. A total final score of 12 or less is considered to indicate remission of sexual dysfunction. |
Countries
United States
Participant flow
Recruitment details
This study screened 57 and included 45 remitted depressed female outpatients aged 18-65. The patients were recruited from December of 2007 through June of 2010 through the Depression Clinical and Research Program in Boston, MA.
Pre-assignment details
Patients were excluded if: diagnosed with a past sexual disorder, currently receiving other treatment for sexual dysfunction, experiencing sexual dysfunction due to underlying medical condition, had recent relationship changes or turmoil unrelated to the sexual dysfunction, or other health or social problems that might influence sexual dysfunction.
Participants by arm
| Arm | Count |
|---|---|
| Maca Root Subjects in this arm will be given 3g/day of maca root for 12 weeks
Maca Root: 3g/day of Maca Root for 12 weeks. | 24 |
| Placebo Subjects in this arm will receive inactive placebo for 12 weeks.
Placebo: Placebo provided by research pharmacy daily for 12 weeks. | 21 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 4 | 3 |
| Overall Study | Physician Decision | 2 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Maca Root | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 21 Participants | 45 Participants |
| Region of Enrollment United States | 24 Participants | 21 Participants | 45 Participants |
| Sex: Female, Male Female | 24 Participants | 21 Participants | 45 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 21 |
| other Total, other adverse events | 17 / 24 | 5 / 21 |
| serious Total, serious adverse events | 0 / 24 | 0 / 21 |
Outcome results
Primary
Proportion of Participants in Remission Based on Arizona Sexual Experience Scale (ASEX) Score of 10 or Less After 12 Weeks of Treatment.
Arizona Sexual Experience Scale (ASEX) consists of five items rating sexual drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm.The range of total score is 5-30 with the higher scores indicating greater sexual dysfunction. A total final score of 10 or less is considered to indicate remission of sexual dysfunction.
Time frame: 12 weeks
Population: Analysis of 42 women who completed at least one clinical assessment after a minimum of seven days of treatment. This included 21 women (14 premenopausal and 7 postmenopausal) randomized to treatment with maca and 21 women (16 premenopausal and 5 postmenopausal) randomized to placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maca Root | Proportion of Participants in Remission Based on Arizona Sexual Experience Scale (ASEX) Score of 10 or Less After 12 Weeks of Treatment. | 2 participants |
| Placebo | Proportion of Participants in Remission Based on Arizona Sexual Experience Scale (ASEX) Score of 10 or Less After 12 Weeks of Treatment. | 1 participants |
Comparison: Treatment groups were compared based on percentage reaching remission thresholds per scale: a total score of 12 (minimally diminished) or less on the MGH-SFQ scale, and a total score of 10 (very strong/very easily/very satisfying) or less on the ASEX.p-value: 0.5595% CI: [0.18, 25.2]Chi-squared
Primary
Proportion of Participants in Remission Based on Massachusetts General Hospital Sexual Functioning Questionnaire (MGH-SFQ) Score of 12 or Less After 12 Weeks of Treatment.
Massachusetts General Hospital-Sexual Functioning Questionnaire (MGH-SFQ) is composed of five items evaluating libido, sexual arousal or excitement, ability to achieve orgasm, ability to achieve and maintain an erection (for men only) and overall sexual satisfaction. Items are rated on a scale of 1 to 6 with a rating of 1 indicating greater than normal functioning and a rating of 6 indicating totally absent functioning. A total final score of 12 or less is considered to indicate remission of sexual dysfunction.
Time frame: 12 weeks
Population: Analysis of 42 women who completed at least one clinical assessment after a minimum of seven days of treatment. This included 21 women (14 premenopausal and 7 postmenopausal) randomized to treatment with maca and 21 women (16 premenopausal and 5 postmenopausal) randomized to placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maca Root | Proportion of Participants in Remission Based on Massachusetts General Hospital Sexual Functioning Questionnaire (MGH-SFQ) Score of 12 or Less After 12 Weeks of Treatment. | 6 participants |
| Placebo | Proportion of Participants in Remission Based on Massachusetts General Hospital Sexual Functioning Questionnaire (MGH-SFQ) Score of 12 or Less After 12 Weeks of Treatment. | 4 participants |
Comparison: Treatment groups were compared based on percentage reaching remission thresholds per scale: a total score of 12 (minimally diminished) or less on the MGH-SFQ scale, and a total score of 10 (very strong/very easily/very satisfying) or less on the ASEX.p-value: 0.4795% CI: [0.4, 7.34]Chi-squared