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Safety and Effectiveness Study of Maca Root to Treat Antidepressant-Induced Sexual Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00181961
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Christina M. Dording, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Depression
Sexual Dysfunction
Intervention Drug: Maca Root
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Maca Root 1500mg Maca Root 3000mg
Hide Arm/Group Description

Patients receiving 1500mg of maca root

Maca Root

Patients receiving 3000mg of maca root

Maca Root

Period Title: Overall Study
Started [1] 7 9
Completed 6 4
Not Completed 1 5
[1]
Protocol defined enrolled as screened participants. Baseline visit determined randomization.
Arm/Group Title Maca Root 1500mg Maca Root 3000mg Total
Hide Arm/Group Description

Patients receiving 1500mg of maca root

Maca Root

Patients receiving 3000mg of maca root

Maca Root

Total of all reporting groups
Overall Number of Baseline Participants 7 9 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 9 participants 16 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
9
 100.0%
16
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 9 participants 16 participants
39  (12) 34  (15) 36  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 9 participants 16 participants
Female
6
  85.7%
8
  88.9%
14
  87.5%
Male
1
  14.3%
1
  11.1%
2
  12.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 9 participants 16 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
7
 100.0%
9
 100.0%
16
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 9 participants 16 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  14.3%
1
  11.1%
2
  12.5%
White
6
  85.7%
8
  88.9%
14
  87.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 9 participants 16 participants
7 9 16
1.Primary Outcome
Title Change in Massachusetts General Hospital Sexual Dysfunction Inventory Scores
Hide Description

Full title: Massachusetts General Hospital Sexual Dysfunction Inventory Minimum score for Men: 5 Minimum score for Women: 4 Maximum score for Men: 30 Maximum score for Women: 24

*One item on the measure is for men only

A score of a 5 (4 for women) indicates improvement in sexual function. A score of 10 (8 for women) indicates no change. A score higher than 10 (8 for women) indicates a level of sexual dysfunction.

Time Frame baseline to endpoint (8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Maca Root 1500mg Maca Root 3000mg
Hide Arm/Group Description:

Patients receiving 1500mg of maca root

Maca Root

Patients receiving 3000mg of maca root

Maca Root

Overall Number of Participants Analyzed 7 9
Mean (Standard Deviation)
Unit of Measure: score on a scale
.249  (2.39) .017  (1.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maca Root 1500mg, Maca Root 3000mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .016
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Maca Root 1500mg Maca Root 3000mg
Hide Arm/Group Description

Patients receiving 1500mg of maca root

Maca Root

Patients receiving 3000mg of maca root

Maca Root

All-Cause Mortality
Maca Root 1500mg Maca Root 3000mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Maca Root 1500mg Maca Root 3000mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/9 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Maca Root 1500mg Maca Root 3000mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/7 (71.43%)      7/9 (77.78%)    
Gastrointestinal disorders     
GI Upset *  2/7 (28.57%)  6 3/9 (33.33%)  4
General disorders     
Headache *  0/7 (0.00%)  0 2/9 (22.22%)  2
Irritability *  1/7 (14.29%)  1 1/9 (11.11%)  1
Urinary Frequency *  0/7 (0.00%)  0 1/9 (11.11%)  2
Sleep issues *  1/7 (14.29%)  3 0/9 (0.00%)  0
Thicker Menstrual Discharge *  0/7 (0.00%)  0 1/9 (11.11%)  1
Fibromyalgia Exacerbation *  1/7 (14.29%)  1 0/9 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Christina Dording
Organization: Massachusetts General Hospital
Phone: 6177249457
EMail: cdording@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Christina M. Dording, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00181961    
Other Study ID Numbers: 2004-P-001269
First Submitted: September 13, 2005
First Posted: September 16, 2005
Results First Submitted: December 3, 2018
Results First Posted: August 21, 2019
Last Update Posted: August 21, 2019