Trial Outcomes & Findings for Study of Maca Root for the Treatment of Antidepressant-Induced Sexual Dysfunction in Females (NCT NCT00568126)
NCT ID: NCT00568126
Last Updated: 2020-08-26
Results Overview
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.
COMPLETED
PHASE3
45 participants
12 weeks
2020-08-26
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
Placebo
Subjects in this arm will receive inactive placebo for 12 weeks.
Placebo: Placebo provided by research pharmacy daily for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
21
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
11
|
9
|
Reasons for withdrawal
| Measure |
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.
|
Placebo
Subjects in this arm will receive inactive placebo for 12 weeks.
Placebo: Placebo provided by research pharmacy daily for 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Physician Decision
|
2
|
2
|
Baseline Characteristics
Study of Maca Root for the Treatment of Antidepressant-Induced Sexual Dysfunction in Females
Baseline characteristics by cohort
| Measure |
Maca Root
n=24 Participants
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.
|
Placebo
n=21 Participants
Subjects in this arm will receive inactive placebo for 12 weeks.
Placebo: Placebo provided by research pharmacy daily for 12 weeks.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Maca Root
n=21 Participants
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.
|
Placebo
n=21 Participants
Subjects in this arm will receive inactive placebo for 12 weeks.
Placebo: Placebo provided by research pharmacy daily for 12 weeks.
|
|---|---|---|
|
Proportion of Participants in Remission Based on Arizona Sexual Experience Scale (ASEX) Score of 10 or Less After 12 Weeks of Treatment.
|
2 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Maca Root
n=21 Participants
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.
|
Placebo
n=21 Participants
Subjects in this arm will receive inactive placebo for 12 weeks.
Placebo: Placebo provided by research pharmacy daily for 12 weeks.
|
|---|---|---|
|
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
|
4 participants
|
Adverse Events
Maca Root
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Maca Root
n=24 participants at risk
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.
|
Placebo
n=21 participants at risk
Subjects in this arm will receive inactive placebo for 12 weeks.
Placebo: Placebo provided by research pharmacy daily for 12 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Acute Vomiting
|
8.3%
2/24 • Number of events 3 • Adverse event data were collected from each patient over 12 weeks of treatment.
Adverse events were recorded by study clinicians in the chart at each biweekly treatment visit over the 12-week course of treatment. The overall duration of the study was from December of 2007 through September of 2010 (2 years and 9 months).
|
0.00%
0/21 • Adverse event data were collected from each patient over 12 weeks of treatment.
Adverse events were recorded by study clinicians in the chart at each biweekly treatment visit over the 12-week course of treatment. The overall duration of the study was from December of 2007 through September of 2010 (2 years and 9 months).
|
|
Respiratory, thoracic and mediastinal disorders
Flu-like symptoms
|
8.3%
2/24 • Number of events 2 • Adverse event data were collected from each patient over 12 weeks of treatment.
Adverse events were recorded by study clinicians in the chart at each biweekly treatment visit over the 12-week course of treatment. The overall duration of the study was from December of 2007 through September of 2010 (2 years and 9 months).
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected from each patient over 12 weeks of treatment.
Adverse events were recorded by study clinicians in the chart at each biweekly treatment visit over the 12-week course of treatment. The overall duration of the study was from December of 2007 through September of 2010 (2 years and 9 months).
|
|
Nervous system disorders
Headache
|
16.7%
4/24 • Number of events 4 • Adverse event data were collected from each patient over 12 weeks of treatment.
Adverse events were recorded by study clinicians in the chart at each biweekly treatment visit over the 12-week course of treatment. The overall duration of the study was from December of 2007 through September of 2010 (2 years and 9 months).
|
9.5%
2/21 • Number of events 2 • Adverse event data were collected from each patient over 12 weeks of treatment.
Adverse events were recorded by study clinicians in the chart at each biweekly treatment visit over the 12-week course of treatment. The overall duration of the study was from December of 2007 through September of 2010 (2 years and 9 months).
|
|
Gastrointestinal disorders
Increased appetite
|
12.5%
3/24 • Number of events 3 • Adverse event data were collected from each patient over 12 weeks of treatment.
Adverse events were recorded by study clinicians in the chart at each biweekly treatment visit over the 12-week course of treatment. The overall duration of the study was from December of 2007 through September of 2010 (2 years and 9 months).
|
0.00%
0/21 • Adverse event data were collected from each patient over 12 weeks of treatment.
Adverse events were recorded by study clinicians in the chart at each biweekly treatment visit over the 12-week course of treatment. The overall duration of the study was from December of 2007 through September of 2010 (2 years and 9 months).
|
|
Gastrointestinal disorders
Weight Gain
|
8.3%
2/24 • Number of events 2 • Adverse event data were collected from each patient over 12 weeks of treatment.
Adverse events were recorded by study clinicians in the chart at each biweekly treatment visit over the 12-week course of treatment. The overall duration of the study was from December of 2007 through September of 2010 (2 years and 9 months).
|
0.00%
0/21 • Adverse event data were collected from each patient over 12 weeks of treatment.
Adverse events were recorded by study clinicians in the chart at each biweekly treatment visit over the 12-week course of treatment. The overall duration of the study was from December of 2007 through September of 2010 (2 years and 9 months).
|
|
Nervous system disorders
Insomnia
|
8.3%
2/24 • Number of events 2 • Adverse event data were collected from each patient over 12 weeks of treatment.
Adverse events were recorded by study clinicians in the chart at each biweekly treatment visit over the 12-week course of treatment. The overall duration of the study was from December of 2007 through September of 2010 (2 years and 9 months).
|
9.5%
2/21 • Number of events 2 • Adverse event data were collected from each patient over 12 weeks of treatment.
Adverse events were recorded by study clinicians in the chart at each biweekly treatment visit over the 12-week course of treatment. The overall duration of the study was from December of 2007 through September of 2010 (2 years and 9 months).
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
8.3%
2/24 • Number of events 2 • Adverse event data were collected from each patient over 12 weeks of treatment.
Adverse events were recorded by study clinicians in the chart at each biweekly treatment visit over the 12-week course of treatment. The overall duration of the study was from December of 2007 through September of 2010 (2 years and 9 months).
|
0.00%
0/21 • Adverse event data were collected from each patient over 12 weeks of treatment.
Adverse events were recorded by study clinicians in the chart at each biweekly treatment visit over the 12-week course of treatment. The overall duration of the study was from December of 2007 through September of 2010 (2 years and 9 months).
|
Additional Information
Dr. David Mischoulon, Director
Depression Clinical and Research Program, Massachusetts General Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place