Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

L-methylfolate Supplementation to OROS-Methylphenidate Pharmacotherapy in ADHD Adults

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: NCT01853280
Recruitment Status : Completed
First Posted : May 14, 2013
Results First Posted : November 14, 2017
Last Update Posted : November 14, 2017
Sponsor:
Collaborator:
Pamlab, Inc.
Information provided by (Responsible Party):
Craig B. Surman, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Interventions Drug: L-methylfolate
Drug: OROS-Methylphenidate
Drug: Placebo
Enrollment 47
Recruitment Details  
Pre-assignment Details The total enrollment number (those who signed informed consent) was 47, however, 3 subjects were either found ineligible or lost to follow up before they could be assigned to an arm of the study. Thus 44 subjects were randomized to the study.
Arm/Group Title L-Methylfolate Placebo (for L-Methylfolate)
Hide Arm/Group Description 15 mg of L-Methylfolate (Deplin) daily for 12 weeks as a supplement to OROS-Methylphenidate. 15 mg matched placebo comparator with open-label OROS-Methylphenidate
Period Title: Overall Study
Started 22 22
Completed 20 16
Not Completed 2 6
Reason Not Completed
Lack of Efficacy             2             2
Lost to Follow-up             0             1
Physician Decision             0             1
Withdrawal by Subject             0             1
Ineligible             0             1
Arm/Group Title L-Methylfolate Placebo (for L-Methylfolate) Total
Hide Arm/Group Description 15 mg of L-Methylfolate (Deplin) daily for 12 weeks as a supplement to OROS-Methylphenidate. 15 mg matched placebo comparator with open-label OROS-Methylphenidate Total of all reporting groups
Overall Number of Baseline Participants 22 22 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
22
 100.0%
44
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 22 participants 44 participants
41.3  (11.4) 37.7  (8.9) 39.96  (10.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
Female
13
  59.1%
14
  63.6%
27
  61.4%
Male
9
  40.9%
8
  36.4%
17
  38.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
Hispanic or Latino
1
   4.5%
3
  13.6%
4
   9.1%
Not Hispanic or Latino
21
  95.5%
19
  86.4%
40
  90.9%
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 22 participants 22 participants 44 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   4.5%
1
   2.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   4.5%
2
   9.1%
3
   6.8%
White
19
  86.4%
17
  77.3%
36
  81.8%
More than one race
1
   4.5%
1
   4.5%
2
   4.5%
Unknown or Not Reported
1
   4.5%
1
   4.5%
2
   4.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 22 participants 22 participants 44 participants
22
 100.0%
22
 100.0%
44
 100.0%
1.Primary Outcome
Title Adult ADHD Investigator Symptom Rating Scale (AISRS)
Hide Description The AISRS is an 18-item questionnaire administered by the clinician assessing each of the individual DSM-IV symptoms of ADHD. Each symptom is rated on a scale of severity from 0 (none) to 3 (severe), and the 18 symptom questions are summed to calculate a total score. The minimum total score is a 0, while the maximum total score is a 54. The AISRS was compared from baseline to completion, over the course of the 12 week study.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
While 44 subjects were randomized to receive the study drug, only 41 subjects actually began taking the medication, and as such were evaluated using the AISRS.
Arm/Group Title L-Methylfolate Placebo (for L-Methylfolate)
Hide Arm/Group Description:
15 mg of L-Methylfolate (Deplin) daily for 12 weeks as a supplement to OROS-Methylphenidate.
15 mg matched placebo comparator with open-label OROS-Methylphenidate
Overall Number of Participants Analyzed 22 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
-22.9  (10.4) -20.8  (11.3)
Time Frame Adverse event data was collected throughout the entire time subjects were enrolled in the study beginning as their screening visit and ending at their week 12 completion visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title L-Methylfolate Placebo (for L-Methylfolate)
Hide Arm/Group Description 15 mg of L-Methylfolate (Deplin) daily for 12 weeks as a supplement to OROS-Methylphenidate. 15 mg matched placebo comparator with open-label OROS-Methylphenidate
All-Cause Mortality
L-Methylfolate Placebo (for L-Methylfolate)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)      0/22 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
L-Methylfolate Placebo (for L-Methylfolate)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/22 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
L-Methylfolate Placebo (for L-Methylfolate)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/22 (90.91%)      19/22 (86.36%)    
Cardiac disorders     
Cardiovascular   3/22 (13.64%)  3 3/22 (13.64%)  11
Gastrointestinal disorders     
Decreased Appetite   7/22 (31.82%)  15 10/22 (45.45%)  29
Nausea/Vomit/Diarrhea   6/22 (27.27%)  18 7/22 (31.82%)  10
General disorders     
Decreased energy   1/22 (4.55%)  1 0/22 (0.00%)  0
Infections and infestations     
Cold/Infection/Allergy   12/22 (54.55%)  17 6/22 (27.27%)  11
Musculoskeletal and connective tissue disorders     
Musculoskeletal   8/22 (36.36%)  19 7/22 (31.82%)  8
Nervous system disorders     
Headache   17/22 (77.27%)  40 6/22 (27.27%)  12
Insomnia   11/22 (50.00%)  24 8/22 (36.36%)  16
Sedation   3/22 (13.64%)  3 3/22 (13.64%)  3
Tense/Jittery   6/22 (27.27%)  11 3/22 (13.64%)  3
Neurological   1/22 (4.55%)  1 3/22 (13.64%)  5
Mucosal Dryness   6/22 (27.27%)  15 10/22 (45.45%)  25
Dizzy/lightheaded   0/22 (0.00%)  0 3/22 (13.64%)  3
Autonomic: Drool/sweat   0/22 (0.00%)  0 2/22 (9.09%)  5
Tics   0/22 (0.00%)  0 1/22 (4.55%)  1
Psychiatric disorders     
Anxious/worried   4/22 (18.18%)  6 3/22 (13.64%)  5
Agitated/irritable   1/22 (4.55%)  4 4/22 (18.18%)  5
Sad/down   3/22 (13.64%)  5 5/22 (22.73%)  5
Reproductive system and breast disorders     
Genitourinary   1/22 (4.55%)  1 1/22 (4.55%)  1
Skin and subcutaneous tissue disorders     
Dermatological   1/22 (4.55%)  1 3/22 (13.64%)  3
Indicates events were collected by 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. Craig Surman
Organization: Massachusetts General Hospital
Phone: 617-726-8422
EMail: csurman@partners.org
Layout table for additonal information
Responsible Party: Craig B. Surman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01853280     History of Changes
Other Study ID Numbers: 2012-P-000379
First Submitted: May 10, 2013
First Posted: May 14, 2013
Results First Submitted: June 19, 2017
Results First Posted: November 14, 2017
Last Update Posted: November 14, 2017