Trial Outcomes & Findings for Study of Maca Root to Treat Sexual Dysfunction Associated With the Treatment Regimen for Bipolar Disorder in Females (NCT NCT00575328)

Last Updated: 2020-09-25

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

8 participants

Primary outcome timeframe

Biweekly from Baseline (week zero) to 12 weeks

Results posted on

2020-09-25

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Maca Root Subjects in this arm will be given 3g/day of Maca Root. Maca Root: 3g/day of Maca Root for 12 weeks.	Placebo Subjects in this arm will receive inactive placebo. Placebo: Placebo provided by research pharmacy daily for 12 weeks.
Overall Study STARTED	4	4
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Maca Root Subjects in this arm will be given 3g/day of Maca Root. Maca Root: 3g/day of Maca Root for 12 weeks.	Placebo Subjects in this arm will receive inactive placebo. Placebo: Placebo provided by research pharmacy daily for 12 weeks.
Overall Study Adverse Event	1	1
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

Study of Maca Root to Treat Sexual Dysfunction Associated With the Treatment Regimen for Bipolar Disorder in Females

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Maca Root n=4 Participants Subjects in this arm will be given 3g/day of Maca Root. Maca Root: 3g/day of Maca Root for 12 weeks.	Placebo n=4 Participants Subjects in this arm will receive inactive placebo. Placebo: Placebo provided by research pharmacy daily for 12 weeks.	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=39 Participants	4 Participants n=41 Participants	8 Participants n=35 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Continuous	37 years STANDARD_DEVIATION 11 • n=39 Participants	37 years STANDARD_DEVIATION 10 • n=41 Participants	37 years STANDARD_DEVIATION 10 • n=35 Participants
Sex: Female, Male Female	4 Participants n=39 Participants	4 Participants n=41 Participants	8 Participants n=35 Participants
Sex: Female, Male Male	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race/Ethnicity, Customized White	4 Participants n=39 Participants	3 Participants n=41 Participants	7 Participants n=35 Participants
Race/Ethnicity, Customized Asian-Hispanic	0 Participants n=39 Participants	1 Participants n=41 Participants	1 Participants n=35 Participants
Region of Enrollment United States	4 Participants n=39 Participants	4 Participants n=41 Participants	8 Participants n=35 Participants
Hamilton D-17 score	6 units on a scale STANDARD_DEVIATION 3 • n=39 Participants	6 units on a scale STANDARD_DEVIATION 2 • n=41 Participants	6 units on a scale STANDARD_DEVIATION 2 • n=35 Participants
Young Mania Rating Scale score	2 units on a scale STANDARD_DEVIATION 1.8 • n=39 Participants	1.5 units on a scale STANDARD_DEVIATION 1.7 • n=41 Participants	1.8 units on a scale STANDARD_DEVIATION 1.7 • n=35 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Maca Root n=3 Participants Subjects in this arm will be given 3g/day of Maca Root. Maca Root: 3g/day of Maca Root for 12 weeks.	Placebo n=3 Participants Subjects in this arm will receive inactive placebo. Placebo: Placebo provided by research pharmacy daily for 12 weeks.
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	1.5 units on a scale Standard Deviation 2.1
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	21.3 units on a scale Standard Deviation 0.6
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	23 units on a scale Standard Deviation 2.8

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Maca Root n=3 Participants Subjects in this arm will be given 3g/day of Maca Root. Maca Root: 3g/day of Maca Root for 12 weeks.	Placebo n=3 Participants Subjects in this arm will receive inactive placebo. Placebo: Placebo provided by research pharmacy daily for 12 weeks.
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	18.7 units on a scale Standard Deviation 2.3
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 5.0	18 units on a scale Standard Deviation 1.7
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	-0.7 units on a scale Standard Deviation 2.1

Adverse Events

Maca Root

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Maca Root n=4 participants at risk Subjects in this arm will be given 3g/day of Maca Root. Maca Root: 3g/day of Maca Root for 12 weeks.	Placebo n=4 participants at risk Subjects in this arm will receive inactive placebo. Placebo: Placebo provided by research pharmacy daily for 12 weeks.
Reproductive system and breast disorders Menorrhagia	25.0% 1/4 • Number of events 1 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.	0.00% 0/4 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.

Other adverse events

Other adverse events
Measure	Maca Root n=4 participants at risk Subjects in this arm will be given 3g/day of Maca Root. Maca Root: 3g/day of Maca Root for 12 weeks.	Placebo n=4 participants at risk Subjects in this arm will receive inactive placebo. Placebo: Placebo provided by research pharmacy daily for 12 weeks.
Gastrointestinal disorders Bloating	0.00% 0/4 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.	25.0% 1/4 • Number of events 1 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.
Gastrointestinal disorders Heartburn symptom	0.00% 0/4 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.	50.0% 2/4 • Number of events 2 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.
Gastrointestinal disorders Nausea	25.0% 1/4 • Number of events 1 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.	0.00% 0/4 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.
Reproductive system and breast disorders Vaginal bleeding	0.00% 0/4 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.	50.0% 2/4 • Number of events 2 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.
Respiratory, thoracic and mediastinal disorders Influenza	25.0% 1/4 • Number of events 1 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.	25.0% 1/4 • Number of events 1 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	25.0% 1/4 • Number of events 1 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.	0.00% 0/4 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/4 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.	25.0% 1/4 • Number of events 1 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.
General disorders Fatigue	25.0% 1/4 • Number of events 1 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.	0.00% 0/4 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.
Psychiatric disorders Anxiety	25.0% 1/4 • Number of events 1 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.	0.00% 0/4 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.
Nervous system disorders Forgetfulness	25.0% 1/4 • Number of events 1 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.	0.00% 0/4 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.
Musculoskeletal and connective tissue disorders Superficial laceration of leg	25.0% 1/4 • Number of events 1 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.	0.00% 0/4 • 2 years. All adverse events were systematically recorded and reported to the Institutional Review Board (IRB). All significant adverse effects were immediately reported upon their discovery and monitored through the following methods: 1) Going over any adverse events with the patient at each study visit 2) holding weekly meetings with the principal investigator and study staff team to review all safety and tolerability issues that were brought up.

Additional Information

Dr. David Mischoulon, Director

Depression Clinical and Research Program, Massachusetts General Hospital

Phone: 617-724-5198

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place