Attention Deficit Hyperactivity DisorderPhase 2NCT00610441
Dose Finding Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)(174007/P05805/MK-8777-003)
A Phase 2 study testing MK-8777 in people with Attention Deficit Hyperactivity Disorder, run by Merck Sharp & Dohme LLC.
Trial summary
This is a Phase 2 multicenter, randomized, double-blind trial of MK-8777 (Org 26576, SCH 900777) in adult subjects with Attention-Deficit/Hyperactivity Disorder (ADHD). MK-8777 or placebo will be administered in a crossover fashion for two 3-week treatment periods. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- MK-8777
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2008to 9 Mar 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- are between 18-50 years, inclusive;
- are male; or female who are non-pregnant, non-lactating and using an acceptable method of birth control (intrauterine device, double-barrier method, hormonal contraceptives); or female of non-childbearing potential if they are a) surgically sterile (tubal ligation, hysterectomy and/or bilateral oophorectomy) and provide documentation of the procedure by operative report or ultrasound scan, or b) post-menopausal for greater than one year with follicle stimulating hormone (FSH) level greater than or equal to 40 mIU/mL at screening. All females must have a negative serum pregnancy test at screening;
- are outpatients;
- provide written informed consent
- are fluent in the language of the investigator,
- are able to discontinue the use of any psychotropic medications for the treatment of ADHD symptoms at screening;
- meet strict operational criteria for adult ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TRTM)
- have a Clinical Global Impression ADHD score of 4 or higher at screening
Who cannot join
- have any clinically significant concurrent medical condition (endocrine, renal, respiratory, cardiovascular, hematological, immunological, cerebrovascular, neurological, anorexia, obesity or malignancy) that has become unstable and may interfere with the interpretation of safety and efficacy evaluations.
- have any clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings at screening that, in the opinion of the investigator, may interfere with the interpretation of safety or efficacy evaluations.
- have any history of liver disease (e.g., cirrhosis, hepatitis), or liver injury;(history of hepatitis A greater than one year prior to screening is acceptable); any abnormal clinically significant findings at screening on liver laboratory parameters (serum glutamic-pyruvic transaminase [SGPT], serum glutamic oxaloacetic transaminase [SGOT], gamma-glutamyltransferase [GGT], lactate dehydrogenase [LDH], bilirubin, albumin, protein, alkaline phosphatase);
- have a seizure disorder beyond childhood or are taking any anticonvulsants to prevent seizures;
- have known serological evidence of human immunodeficiency virus (HIV) antibody;
- have a positive test result at screening on hepatitis B surface antigen or hepatitis A immunoglobulin M (IgM) antibodies or hepatitis C total antibodies;
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- are pregnant as confirmed by a positive serum pregnancy test at screening;
- have QTc values >450 msec at screening using Fridericia's QTc formula;
- have a confirmed positive result in the alcohol/drug screen test for alcohol, illegal or non-prescribed drugs at screening (except marijuana/ tetrahydrocannabinol [THC]);
- have a confirmed positive result in the alcohol/drug screen re-test for marijuana/THC;
- have current or lifetime history of bipolar and psychotic disorders;
- have a current major depression disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, panic disorder and eating disorder (also if treated but not currently symptomatic);
- have a current comorbid dysthymia or social anxiety disorder that is currently treated with psychotropic medication;
- have a current untreated social anxiety disorder that may interfere with the assessment of ADHD in the investigator's opinion;
- present an imminent risk of self-harm or harm to others;
- have any history of a significant suicide attempt, or possess a current risk of attempting suicide, in the investigator's opinion, based on clinical interview and responses provided on the Beck Scale for Suicidal Ideation (BSS);
- have a history of jailing or imprisonment in the past 6 months due to worsening of symptoms of ADHD;
About this study
Official title: A Double Blind, Placebo Controlled, Randomized, Two Period 4-Arm Trial to Investigate the Dose-Related Efficacy and Safety of Org 26576 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
This is a Phase 2 multicenter, randomized, double-blind trial of MK-8777 (Org 26576, SCH 900777) in adult subjects with Attention-Deficit/Hyperactivity Disorder (ADHD). MK-8777 or placebo will be administered in a crossover fashion for two 3-week treatment periods. The two 3-week treatment periods will be separated by a 2-week placebo washout period.
The primary objective is to compare the efficacy of various doses of MK-8777 to that of placebo in the treatment of ADHD symptoms in adults.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- MK-8777, Placebo
- Keywords
- randomized, double blind, placebo controlled
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-8777Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| MK-8777 FD→PBO | Experimental | Participants receive a fixed dose (FD) of MK-8777 100 mg twice each day (BID) for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of placebo (PBO) BID for 3 weeks (Treatment Period 2). Receives: Drug: MK-8777; Drug: Placebo |
| PBO→MK-8777 FD | Experimental | Participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks (Treatment Period 2). Receives: Drug: MK-8777; Drug: Placebo |
| MK-8777 RD→PBO | Experimental | Participants receive rising doses (RD) of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of placebo BID for 3 weeks (Treatment Period 2). Receives: Drug: MK-8777; Drug: Placebo |
| PBO→MK-8777 RD | Placebo comparator | Participants receive rising doses of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 2). Receives: Drug: MK-8777; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Score
The AISRS is an 18-item clinician-rated instrument for assessing the 18 core symptoms of ADHD corresponding to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnostic symptoms for adults. Based on the clinician's rating for each of the symptoms using a 4-point scale (0=None to 3=Severe), the AISRS total score is derived by summing the score assigned to each of the 18 symptoms. Scores can range from 0 to 54, with a higher score indicating a more severe ADHD symptoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2. For the statistical analyses, the average score from Day 14 and Day 21 was used.
Measured: Baseline (BL) and Day 7, Day 14, Day 21
Secondary outcomes (21)
Percentage of Participants With at Least a 30% Reduction From Baseline in AISRS Score
The AISRS is an 18-item clinician-rated instrument for assessing the 18 core symptoms of ADHD corresponding to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnostic symptoms for adults. Based on the clinician's rating for each of the symptoms using a 4-point scale (0=None to 3=Severe), the AISRS total score is derived by summing the score assigned to each of the 18 symptoms. Scores can range from 0 to 54, with a higher score indicating a more severe ADHD symptoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2. Reduction was defined as the relative change from the baseline score within a treatment period to post-baseline score within that treatment period.
Measured: Baseline and Day 21
Percentage of Participants With at Least a 50% Reduction From Baseline in AISRS Score
The AISRS is an 18-item clinician-rated instrument for assessing the 18 core symptoms of ADHD corresponding to the DSM-IV diagnostic symptoms for adults. Based on the clinician's rating for each of the symptoms using a 4-point scale (0=None to 3=Severe), the AISRS total score is derived by summing the score assigned to each of the 18 symptoms. Scores can range from 0 to 54, with a higher score indicating a more severe ADHD symptoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2. Reduction was defined as the relative change from the baseline score within a treatment period to post-baseline score within that treatment period.
Measured: Baseline and Day 21
Percentage of Participants Who Experience At Least One Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product. AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
Measured: Up to 7 days after last dose of study drug (Up to 63 days)
Percentage of Participants Who Discontinue Study Drug Due to an AE
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product. AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
Measured: Up to last dose of study drug (Up to 56 days)
Percentage of Participants With Clinician Global Impression Scale - Severity (CGI-S) Category Scores
The CGI-S is a 7-point clinician-rated scale for assessing the global severity of ADHD. Scores could range from 1=Normal, not at all ill to 7=Among the most extremely ill, with a higher score indicating more severe illness. Categorization was as follows: 1=Normal, not at all ill and Borderline mentally ill; 2=Mildly ill; 3=Moderately ill and 4=Markedly ill, Severely ill and Among the most extremely ill patients, with a higher category indicating more severe illness. Analysis of CGI-S was performed using a proportional odds model. For statistical analyses, CGI-S assessments were condensed to one assessment of severity per treatment period by taking the most severe score at the second and third visits within a treatment period.
Measured: Days 14-21
Percentage of Participants With Clinician Global Impression Scale - Improvement (CGI-I) Scores
The CGI-I is a 7-point clinician-rated scale for assessing the global improvement of ADHD. Scores could range from 1=Very much improved to 4=No change to 7=Very much worse, with a lower score indicating the most improvement. Analysis of CGI-I was performed using a proportional odds model. For statistical analyses, CGI-I assessments were condensed to one assessment of improvement per treatment period by taking the worst improvement score at the second and third visits within a treatment period.
Measured: Days 14-21
Change From Baseline in Epworth Sleepiness Scale (ESS) Score
The ESS is an 8-item scale used to assess sleepiness. The test consists of a list of 8 situations in which participants rate their tendency to become sleepy on a scale of 0=Would never doze to 3=High chance of dozing. The scores for each of the 8 situations are added to create a total score on a scale with a range from of 0 to 24. A higher score indicates a greater degree of sleepiness. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.
Measured: Baseline and Day 7, Day 14, Day 21
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score
The PSQI is a participant-rated scale to assess the quality of sleep. The PSQI consists of 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component score can range from 0=better (i.e., 0 times per month) to 3=worse (i.e., 3 or more times per week). The sum of these 7 component scores yields one total score with a range of 0 (better) to 21 (worse). A total PSQI score <=5 is associated with good sleep quality; a total score >5 is associated with poor sleep quality. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.
Measured: Baseline and Day 7, Day 14, Day 21
Change From Baseline in Quick Inventory of Depression Symptomology - Clinician Rating (QIDS-C) Score
The QIDS-C is a clinician-administered rating scale to measure the severity of depressive symptoms within the 9 DSM-IV major depression disorder symptom (MDD) domains: depressed mood, loss of interest or pleasure, concentration/decision making, self-outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes. There is one score (0=none to 3=severe) for each of the of the 9 domains. The total score is obtained by adding the scores for each of the 9 symptom domains. QIDS-C total scores can range from 0 to 27, with a higher score indicating more severe depression. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.
Measured: Baseline and Day 7, Day 14, Day 21
Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Score
The TASS is a participant-administered scale to assess study drug effects in the evening. Participants respond to 18 questions about ADHD symptoms, with scores from 0=Not at all to 3=Severe. Total scores can range from 0 to 54, with a higher score indicating more severe ADHD symtoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.
Measured: Baseline and Day 7, Day 14, Day 21
Computerized Cognition Assessment: Cognitive Flexibility
Cognition was assessed by a computerized cognitive testing (©CNS Vital Signs, Chapel Hill, NC) battery consisting of neuropsychological tests that measure the cognitive domain of cognitive flexibility (score range: -200 to 200), with a higher score indicating better cognition.
Measured: Baseline, Day 21
Computerized Cognition Assessment: Complex Attention
Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of complex attention (score range: 0 to 250), with a lower score indicating better cognition.
Measured: Baseline, Day 21
Computerized Cognition Assessment: Composite Memory
Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of composite memory (score range: -120 to 120), with a higher score indicating better cognition.
Measured: Baseline, Day 21
Computerized Cognition Assessment: Executive Functioning
Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of executive functioning (score range: -200 to 200), with a higher score indicating better cognition.
Measured: Baseline, Day 21
Computerized Cognition Assessment: Speed of Processing
Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of speed of processing (score range: -1000 to 200), with a higher score indicating better cognition.
Measured: Baseline, Day 21
Computerized Cognition Assessment: Reaction Time
Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of reaction time (lowest time possible is 0 msec), with a lower reaction time indicating better cognition.
Measured: Baseline, Day 21
Computerized Cognition Assessment: Reasoning
Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of reasoning (score range: -15 to 15), with a higher score indicating better cognition.
Measured: Baseline, Day 21
Computerized Cognition Assessment: Sustained Attention
Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of sustained attention (score range -120 to 120), with a higher score indicating better cognition.
Measured: Baseline, Day 21
Computerized Cognition Assessment: Verbal Memory
Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of verbal memory (score range: -60 to 60), with a higher score indicating better cognition.
Measured: Baseline, Day 21
Computerized Cognition Assessment: Visual Memory
Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of visual memory (score range: -60 to 60), with a higher score indicating better cognition.
Measured: Baseline, Day 21
Computerized Cognition Assessment: Working Memory
Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of working memory (score range: -48 to 48), with a higher score indicating better cognition.
Measured: Baseline, Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study start1 Apr 2008
- Primary completion2 Mar 2009
- Study completion9 Mar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610441
- Sponsor's protocol ID
- P05805
- Other IDs
- 174007
- Status last verified
- Sep 2018
- First submitted
- 28 Jan 2008
- Last updated
- 24 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo Controlled, Randomized, Two Period 4-Arm Trial to Investigate the Dose-Related Efficacy and Safety of Org 26576 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00610441
- Acronym / sponsor ID
- P05805
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- randomized, double blind, placebo controlled
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2008 (actual)
- Primary completion
- 2 Mar 2009 (actual)
- Study completion
- 9 Mar 2009 (actual)
- First posted
- 8 Feb 2008 (estimated)
- Results
- Posted 29 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2 multicenter, randomized, double-blind trial of MK-8777 (Org 26576, SCH 900777) in adult subjects with Attention-Deficit/Hyperactivity Disorder (ADHD). MK-8777 or placebo will be administered in a crossover fashion for two 3-week treatment periods. The two 3-week treatment periods will be separated by a 2-week placebo washout period.
The primary objective is to compare the efficacy of various doses of MK-8777 to that of placebo in the treatment of ADHD symptoms in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MK-8777 FD→PBO | Experimental | Drug: MK-8777, Drug: PlaceboParticipants receive a fixed dose (FD) of MK-8777 100 mg twice each day (BID) for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of placebo (PBO) BID for 3 weeks (Treatment Period 2). |
| PBO→MK-8777 FD | Experimental | Drug: MK-8777, Drug: PlaceboParticipants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks (Treatment Period 2). |
| MK-8777 RD→PBO | Experimental | Drug: MK-8777, Drug: PlaceboParticipants receive rising doses (RD) of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of placebo BID for 3 weeks (Treatment Period 2). |
| PBO→MK-8777 RD | Placebo comparator | Drug: MK-8777, Drug: PlaceboParticipants receive rising doses of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 2). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- are between 18-50 years, inclusive;
- are male; or female who are non-pregnant, non-lactating and using an acceptable method of birth control (intrauterine device, double-barrier method, hormonal contraceptives); or female of non-childbearing potential if they are a) surgically sterile (tubal ligation, hysterectomy and/or bilateral oophorectomy) and provide documentation of the procedure by operative report or ultrasound scan, or b) post-menopausal for greater than one year with follicle stimulating hormone (FSH) level greater than or equal to 40 mIU/mL at screening. All females must have a negative serum pregnancy test at screening;
- are outpatients;
- provide written informed consent
- are fluent in the language of the investigator,
Key exclusion criteria (17 listed)
- have any clinically significant concurrent medical condition (endocrine, renal, respiratory, cardiovascular, hematological, immunological, cerebrovascular, neurological, anorexia, obesity or malignancy) that has become unstable and may interfere with the interpretation of safety and efficacy evaluations.
- have any clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings at screening that, in the opinion of the investigator, may interfere with the interpretation of safety or efficacy evaluations.
- have any history of liver disease (e.g., cirrhosis, hepatitis), or liver injury;(history of hepatitis A greater than one year prior to screening is acceptable); any abnormal clinically significant findings at screening on liver laboratory parameters (serum glutamic-pyruvic transaminase [SGPT], serum glutamic oxaloacetic transaminase [SGOT], gamma-glutamyltransferase [GGT], lactate dehydrogenase [LDH], bilirubin, albumin, protein, alkaline phosphatase);
- have a seizure disorder beyond childhood or are taking any anticonvulsants to prevent seizures;
- have known serological evidence of human immunodeficiency virus (HIV) antibody;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-8777 | Drug | MK-8777 FD→PBO, MK-8777 RD→PBO, PBO→MK-8777 FD, PBO→MK-8777 RD |
| Placebo | Drug | MK-8777 FD→PBO, MK-8777 RD→PBO, PBO→MK-8777 FD, PBO→MK-8777 RD |
Primary outcome
Change From Baseline in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Score
Time frame: Baseline (BL) and Day 7, Day 14, Day 21
The AISRS is an 18-item clinician-rated instrument for assessing the 18 core symptoms of ADHD corresponding to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnostic symptoms for adults. Based on the clinician's rating for each of the symptoms using a 4-point scale (0=None to 3=Severe), the AISRS total score is derived by summing the score assigned to each of the 18 symptoms. Scores can range from 0 to 54, with a higher score indicating a more severe ADHD symptoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2. For the statistical analyses, the average score from Day 14 and Day 21 was used.
21 secondary outcomes
Percentage of Participants With at Least a 30% Reduction From Baseline in AISRS Score
Time frame: Baseline and Day 21
Percentage of Participants With at Least a 50% Reduction From Baseline in AISRS Score
Time frame: Baseline and Day 21
Percentage of Participants Who Experience At Least One Adverse Event (AE)
Time frame: Up to 7 days after last dose of study drug (Up to 63 days)
Percentage of Participants Who Discontinue Study Drug Due to an AE
Time frame: Up to last dose of study drug (Up to 56 days)
Percentage of Participants With Clinician Global Impression Scale - Severity (CGI-S) Category Scores
Time frame: Days 14-21
Percentage of Participants With Clinician Global Impression Scale - Improvement (CGI-I) Scores
Time frame: Days 14-21
Change From Baseline in Epworth Sleepiness Scale (ESS) Score
Time frame: Baseline and Day 7, Day 14, Day 21
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Baseline and Day 7, Day 14, Day 21
Change From Baseline in Quick Inventory of Depression Symptomology - Clinician Rating (QIDS-C) Score
Time frame: Baseline and Day 7, Day 14, Day 21
Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Score
Time frame: Baseline and Day 7, Day 14, Day 21
Computerized Cognition Assessment: Cognitive Flexibility
Time frame: Baseline, Day 21
Computerized Cognition Assessment: Complex Attention
Time frame: Baseline, Day 21
Computerized Cognition Assessment: Composite Memory
Time frame: Baseline, Day 21
Computerized Cognition Assessment: Executive Functioning
Time frame: Baseline, Day 21
Computerized Cognition Assessment: Speed of Processing
Time frame: Baseline, Day 21
Computerized Cognition Assessment: Reaction Time
Time frame: Baseline, Day 21
Computerized Cognition Assessment: Reasoning
Time frame: Baseline, Day 21
Computerized Cognition Assessment: Sustained Attention
Time frame: Baseline, Day 21
Computerized Cognition Assessment: Verbal Memory
Time frame: Baseline, Day 21
Computerized Cognition Assessment: Visual Memory
Time frame: Baseline, Day 21
Computerized Cognition Assessment: Working Memory
Time frame: Baseline, Day 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK-8777 in people with Attention Deficit Hyperactivity Disorder, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Score (time frame: Baseline (BL) and Day 7, Day 14, Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.