Trial Outcomes & Findings for Genetic Modulation of Working Memory in Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT01351272)
NCT ID: NCT01351272
Last Updated: 2024-08-15
Results Overview
Functional brain activity in right Superior Frontal Gyrus (SFG) during the working memory task post treatment as measured by fMRI. For each participant and conditions the estimated parameters are metric, and can be further analysed with ANOVAs or t-tests.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
41 participants
Primary outcome timeframe
6 weeks
Results posted on
2024-08-15
Participant Flow
Study Start: May 2011 Primary Completion: December 2012 Study Completion: March 2013 Wuerzburg University Hospital
Participant milestones
| Measure |
Methylphenidate, Non-retard
Methylphenidate, non-retard: Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg. Within this double blind study the same procedure is applied for the placebo condition.
|
Control: Placebo
For placebo treatment the same procedure was applied like in the verum condition
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
16
|
|
Overall Study
COMPLETED
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Methylphenidate, Non-retard
n=19 Participants
Methylphenidate, non-retard: Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg. Within this double blind study the same procedure is applied for the placebo condition.
|
Control: Placebo
n=16 Participants
For placebo treatment the same procedure was applied like in the verum condition
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.2 years
STANDARD_DEVIATION 9.7 • n=19 Participants
|
35.3 years
STANDARD_DEVIATION 10.2 • n=16 Participants
|
36.3 years
STANDARD_DEVIATION 9.9 • n=35 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=19 Participants
|
7 Participants
n=16 Participants
|
16 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=19 Participants
|
9 Participants
n=16 Participants
|
19 Participants
n=35 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Germany
|
19 participants
n=19 Participants
|
16 participants
n=16 Participants
|
35 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: lost of data due to fmri specific issues
Functional brain activity in right Superior Frontal Gyrus (SFG) during the working memory task post treatment as measured by fMRI. For each participant and conditions the estimated parameters are metric, and can be further analysed with ANOVAs or t-tests.
Outcome measures
| Measure |
Methylphenidate, Non-retard
n=14 Participants
Methylphenidate, non-retard: Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg. Within this double blind study the same procedure is applied for the placebo condition.
|
Control: Placebo
n=13 Participants
For placebo treatment the same procedure was applied like in the verum condition
|
|---|---|---|
|
Brain Activation
|
0.19 Beta weights of contrast
Standard Error 0.09
|
-0.08 Beta weights of contrast
Standard Error 0.08
|
SECONDARY outcome
Timeframe: 6 weeksAccuracy for the working memory paradigm at post. Accuracy was defined as the ratio of correct responses (correctly pressed and correctly not pressed) to total number of stimuli. Higher values indicate better perfromance.The theoretical range goes from 0 to 1.
Outcome measures
| Measure |
Methylphenidate, Non-retard
n=10 Participants
Methylphenidate, non-retard: Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg. Within this double blind study the same procedure is applied for the placebo condition.
|
Control: Placebo
n=11 Participants
For placebo treatment the same procedure was applied like in the verum condition
|
|---|---|---|
|
Neuropsychology
|
0.97 accuracy index
Standard Deviation 0.03
|
0.98 accuracy index
Standard Deviation 0.01
|
SECONDARY outcome
Timeframe: 6 weeksChanges in CAARS scale ( T-values, 50 indicates the population mean with a standard deviation of 10) from pre to post. Higher T values indicate higher symptoms. T-score over 60 indicates clinically relevant ADHS symptoms More negative values of the difference indicate higher symptom reduction, therefore a better outcome. Range of T-values for pre and post measurements between 35 and 90, potential range for differences -55 to +55
Outcome measures
| Measure |
Methylphenidate, Non-retard
n=19 Participants
Methylphenidate, non-retard: Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg. Within this double blind study the same procedure is applied for the placebo condition.
|
Control: Placebo
n=15 Participants
For placebo treatment the same procedure was applied like in the verum condition
|
|---|---|---|
|
ADHD Core Symptoms: Measured by Conners Adult ADHD Rating Scales (CAARS), Inattention Scale
|
-18.9 T-score
Standard Error 3.76
|
-12 T-score
Standard Error 4.44
|
Adverse Events
Methylphenidate, Non-retard
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Control: Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methylphenidate, Non-retard
n=19 participants at risk
Methylphenidate, non-retard: Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg. Within this double blind study the same procedure is applied for the placebo condition.
|
Control: Placebo
n=16 participants at risk
For placebo treatment the same procedure was applied like in the verum condition
|
|---|---|---|
|
Gastrointestinal disorders
Appendicitis
|
5.3%
1/19 • Number of events 1 • through study completion at day 70
|
0.00%
0/16 • through study completion at day 70
|
Other adverse events
| Measure |
Methylphenidate, Non-retard
n=19 participants at risk
Methylphenidate, non-retard: Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg. Within this double blind study the same procedure is applied for the placebo condition.
|
Control: Placebo
n=16 participants at risk
For placebo treatment the same procedure was applied like in the verum condition
|
|---|---|---|
|
Nervous system disorders
Headache
|
52.6%
10/19 • Number of events 12 • through study completion at day 70
|
25.0%
4/16 • Number of events 4 • through study completion at day 70
|
|
Surgical and medical procedures
Therapeutic apical closure
|
5.3%
1/19 • Number of events 1 • through study completion at day 70
|
0.00%
0/16 • through study completion at day 70
|
|
Cardiac disorders
Labile blood pressure
|
10.5%
2/19 • Number of events 2 • through study completion at day 70
|
0.00%
0/16 • through study completion at day 70
|
|
Cardiac disorders
Palpitations
|
5.3%
1/19 • Number of events 1 • through study completion at day 70
|
0.00%
0/16 • through study completion at day 70
|
|
Respiratory, thoracic and mediastinal disorders
Pain in throat
|
10.5%
2/19 • Number of events 2 • through study completion at day 70
|
0.00%
0/16 • through study completion at day 70
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
5.3%
1/19 • Number of events 1 • through study completion at day 70
|
0.00%
0/16 • through study completion at day 70
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
5.3%
1/19 • Number of events 1 • through study completion at day 70
|
0.00%
0/16 • through study completion at day 70
|
|
Ear and labyrinth disorders
Dizziness postural
|
5.3%
1/19 • Number of events 1 • through study completion at day 70
|
12.5%
2/16 • Number of events 2 • through study completion at day 70
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
5.3%
1/19 • Number of events 1 • through study completion at day 70
|
0.00%
0/16 • through study completion at day 70
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/19 • through study completion at day 70
|
6.2%
1/16 • Number of events 1 • through study completion at day 70
|
|
Psychiatric disorders
Feeling agitated
|
5.3%
1/19 • Number of events 1 • through study completion at day 70
|
0.00%
0/16 • through study completion at day 70
|
|
Psychiatric disorders
Difficulty sleeping
|
5.3%
1/19 • Number of events 3 • through study completion at day 70
|
12.5%
2/16 • Number of events 2 • through study completion at day 70
|
|
Gastrointestinal disorders
Infection of gastrointestinal tract
|
5.3%
1/19 • Number of events 2 • through study completion at day 70
|
0.00%
0/16 • through study completion at day 70
|
|
Gastrointestinal disorders
Acid reflux
|
5.3%
1/19 • Number of events 1 • through study completion at day 70
|
0.00%
0/16 • through study completion at day 70
|
|
Gastrointestinal disorders
diarrhea
|
5.3%
1/19 • Number of events 1 • through study completion at day 70
|
0.00%
0/16 • through study completion at day 70
|
|
Gastrointestinal disorders
Nausea
|
10.5%
2/19 • Number of events 3 • through study completion at day 70
|
0.00%
0/16 • through study completion at day 70
|
|
Gastrointestinal disorders
Stomach ache
|
5.3%
1/19 • Number of events 1 • through study completion at day 70
|
6.2%
1/16 • Number of events 1 • through study completion at day 70
|
|
Reproductive system and breast disorders
menstrual problem
|
5.3%
1/19 • Number of events 1 • through study completion at day 70
|
0.00%
0/16 • through study completion at day 70
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
1/19 • Number of events 3 • through study completion at day 70
|
18.8%
3/16 • Number of events 4 • through study completion at day 70
|
|
Musculoskeletal and connective tissue disorders
cramp
|
5.3%
1/19 • Number of events 2 • through study completion at day 70
|
0.00%
0/16 • through study completion at day 70
|
|
Musculoskeletal and connective tissue disorders
low back pain
|
10.5%
2/19 • Number of events 3 • through study completion at day 70
|
12.5%
2/16 • Number of events 2 • through study completion at day 70
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/19 • through study completion at day 70
|
6.2%
1/16 • Number of events 1 • through study completion at day 70
|
|
Musculoskeletal and connective tissue disorders
Tendinitis
|
0.00%
0/19 • through study completion at day 70
|
6.2%
1/16 • Number of events 1 • through study completion at day 70
|
|
Musculoskeletal and connective tissue disorders
rupture of meniscus of knee
|
0.00%
0/19 • through study completion at day 70
|
6.2%
1/16 • Number of events 1 • through study completion at day 70
|
|
Infections and infestations
common cold
|
31.6%
6/19 • Number of events 8 • through study completion at day 70
|
6.2%
1/16 • Number of events 1 • through study completion at day 70
|
|
Infections and infestations
Herpes zoster
|
5.3%
1/19 • Number of events 1 • through study completion at day 70
|
0.00%
0/16 • through study completion at day 70
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place