Bipolar Disorder, Sexual Dysfunction
Conditions
Keywords
Sexual Dysfunction, Bipolar Disorder
Brief summary
The purpose of this research study is to find out whether Maca Root is effective for treating sexual dysfunction in females that is caused by the treatment for bipolar disorder. 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. We suspect that Maca Root will result in a significant reduction in sexual dysfunction when compared to a placebo group.
Detailed description
The study seeks to enroll 80 patients with sexual dysfunction associated with their bipolar medication regimen over 24 months. Subjects were outpatient females between 18 and 80 years old with no significant symptoms of mania (Young Mania Rating Scale score\<10), and who have been on a steady regimen of medications to treat bipolar disorder for at least 8 weeks, with a stable dose for at least 4 weeks. Subjects will be randomly assigned in a double blind manner to receive 3000 mg/day of maca root or identical placebo for 12 weeks to determine whether maca root is more effective than placebo for the treatment of sexual dysfunction associated with treatment regimens for bipolar disorder.
Interventions
DRUGMaca Root
3g/day of Maca Root for 12 weeks.
DRUGPlacebo
Placebo provided by research pharmacy daily for 12 weeks.
Sponsors
National Alliance for Research on Schizophrenia and Depression
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
All subjects, investigators, and clinical assessors were blinded to the intervention.
Intervention model description
Maca root will be compared against inactive placebo as a treatment for sexual dysfunction induced by psychotropic drugs.
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 on a steady regimen to treat bipolar disorder, including monotherapy with or any combination of antidepressants, mood stabilizers, atypical antipsychotics, or benzodiazepines, for at least 8 weeks; and is currently on a stable dose of that regimen for at least 4 weeks * Subject is currently euthymic (Hamilton-D scale score \< 10) and is without significant anxiety symptoms (Hamilton-A \< 10). Her bipolar disorder must be in remission (Young Mania Rating Scale score \< 10) * Subject must have had no sexual dysfunction prior to taking psychotropic medications and there must be a clear temporal relationship between the sexual dysfunction and the treatment for bipolar disorder * 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 bipolar treatment regimen and is 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 * 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 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 bipolar treatment regimen and had no sexual dysfunction while on the same hormone therapy regimen, and there is no change in the hormone replacement therapy 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 bipolar medication 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 |
|---|---|---|
| Reductions in Arizona Sexual Experience Scale (ASEX) Scores Over 12 Weeks of Treatment. | Biweekly from Baseline (week zero) to 12 weeks | The ASEX scale 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 from 5-30, with the higher scores indicating greater sexual dysfunction. Scores were obtained at baseline and at all biweekly assessment visits over the 12 weeks of treatment. |
| Reductions in Massachusetts General Hospital Sexual Dysfunction (MGH-SD) Inventory Scores Over 12 Weeks of Treatment. | Biweekly from Baseline (week zero) to 12 weeks | This instrument 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. Possible total scores range from 5-30, with higher scores indicating greater pathology. Scores were obtained at baseline and at each biweekly assessment visit over 12 weeks of treatment. |
Countries
United States
Participant flow
Recruitment details
Female subjects with remitted bipolar disorder and sexual dysfunction associated with their bipolar medication treatment regimens were recruited from 2/26/2008 to 4/26/2010, all at the Massachusetts General Hospital Depression Clinical and Research Program.
Pre-assignment details
Subjects underwent a screening visit to determine eligibility. Those subjects deemed eligible returned a week later for a baseline visit, where eligibility was confirmed prior to treatment assignment. Subjects who for any reason no longer met entry criteria were discontinued and offered alternative treatment options.
Participants by arm
| Arm | Count |
|---|---|
| Maca Root Subjects in this arm will be given 3g/day of Maca Root.
Maca Root: 3g/day of Maca Root for 12 weeks. | 4 |
| Placebo Subjects in this arm will receive inactive placebo.
Placebo: Placebo provided by research pharmacy daily for 12 weeks. | 4 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Placebo | Maca Root | 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 | 4 Participants | 4 Participants | 8 Participants |
| Age, Continuous | 37 years STANDARD_DEVIATION 10 | 37 years STANDARD_DEVIATION 11 | 37 years STANDARD_DEVIATION 10 |
| Hamilton D-17 score | 6 units on a scale STANDARD_DEVIATION 2 | 6 units on a scale STANDARD_DEVIATION 3 | 6 units on a scale STANDARD_DEVIATION 2 |
| Race/Ethnicity, Customized Asian-Hispanic | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 3 Participants | 4 Participants | 7 Participants |
| Region of Enrollment United States | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Young Mania Rating Scale score | 1.5 units on a scale STANDARD_DEVIATION 1.7 | 2 units on a scale STANDARD_DEVIATION 1.8 | 1.8 units on a scale STANDARD_DEVIATION 1.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 3 / 4 | 2 / 4 |
| serious Total, serious adverse events | 1 / 4 | 0 / 4 |
Outcome results
Primary
Reductions in Arizona Sexual Experience Scale (ASEX) Scores Over 12 Weeks of Treatment.
The ASEX scale 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 from 5-30, with the higher scores indicating greater sexual dysfunction. Scores were obtained at baseline and at all biweekly assessment visits over the 12 weeks of treatment.
Time frame: Biweekly from Baseline (week zero) to 12 weeks
Population: Intent to treat sample. Subjects with at least one post baseline visit recorded with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Maca Root | Reductions in Arizona Sexual Experience Scale (ASEX) Scores Over 12 Weeks of Treatment. | ASEX-Baseline Score | 23.7 units on a scale | Standard Deviation 1.5 |
| Maca Root | Reductions in Arizona Sexual Experience Scale (ASEX) Scores Over 12 Weeks of Treatment. | ASEX-Final Score | 23.3 units on a scale | Standard Deviation 3.8 |
| Maca Root | Reductions in Arizona Sexual Experience Scale (ASEX) Scores Over 12 Weeks of Treatment. | ASEX-Change in Score | -0.3 units on a scale | Standard Deviation 4.2 |
| Placebo | Reductions in Arizona Sexual Experience Scale (ASEX) Scores Over 12 Weeks of Treatment. | ASEX-Baseline Score | 21.3 units on a scale | Standard Deviation 0.6 |
| Placebo | Reductions in Arizona Sexual Experience Scale (ASEX) Scores Over 12 Weeks of Treatment. | ASEX-Final Score | 23 units on a scale | Standard Deviation 2.8 |
| Placebo | Reductions in Arizona Sexual Experience Scale (ASEX) Scores Over 12 Weeks of Treatment. | ASEX-Change in Score | 1.5 units on a scale | Standard Deviation 2.1 |
Comparison: Null hypothesis: There will be no difference in clinical improvement (i.e. change in ASEX score) between treatment arms. No formal power analysis was carried out, given the small study sample.p-value: 0.6295% CI: [-8.7, 12.3]t-test, 2 sided
Primary
Reductions in Massachusetts General Hospital Sexual Dysfunction (MGH-SD) Inventory Scores Over 12 Weeks of Treatment.
This instrument 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. Possible total scores range from 5-30, with higher scores indicating greater pathology. Scores were obtained at baseline and at each biweekly assessment visit over 12 weeks of treatment.
Time frame: Biweekly from Baseline (week zero) to 12 weeks
Population: Intent to treat sample. Subjects with at least one post baseline visit recorded with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Maca Root | Reductions in Massachusetts General Hospital Sexual Dysfunction (MGH-SD) Inventory Scores Over 12 Weeks of Treatment. | Change in MGH-SD Score | -4.3 units on a scale | Standard Deviation 6.1 |
| Maca Root | Reductions in Massachusetts General Hospital Sexual Dysfunction (MGH-SD) Inventory Scores Over 12 Weeks of Treatment. | MGH-SD Score-Baseline | 21 units on a scale | Standard Deviation 2 |
| Maca Root | Reductions in Massachusetts General Hospital Sexual Dysfunction (MGH-SD) Inventory Scores Over 12 Weeks of Treatment. | MGH-SD Score-Final | 16.7 units on a scale | Standard Deviation 5 |
| Placebo | Reductions in Massachusetts General Hospital Sexual Dysfunction (MGH-SD) Inventory Scores Over 12 Weeks of Treatment. | MGH-SD Score-Final | 18 units on a scale | Standard Deviation 1.7 |
| Placebo | Reductions in Massachusetts General Hospital Sexual Dysfunction (MGH-SD) Inventory Scores Over 12 Weeks of Treatment. | Change in MGH-SD Score | -0.7 units on a scale | Standard Deviation 2.1 |
| Placebo | Reductions in Massachusetts General Hospital Sexual Dysfunction (MGH-SD) Inventory Scores Over 12 Weeks of Treatment. | MGH-SD Score-Baseline | 18.7 units on a scale | Standard Deviation 2.3 |
Comparison: Null hypothesis: There will be no difference in clinical improvement (i.e. change in MGH-SD score) between treatment arms. No formal power analysis was carried out, given the small study sample.p-value: 0.3895% CI: [-6.7, 13.97]t-test, 2 sided