Dose Finding Study in Adults With Attention Deficit Hyperactivity Disorder (ADHD)(174007)(COMPLETED)(P05805)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00610441
First received: January 28, 2008
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

This is a Phase 2 multicenter, randomized, double-blind trial in adult subjects with Attention-Deficit Hyperactivity Disorder (ADHD).

The Primary objective is to compare the efficacy of various doses of Org 26576 to that of placebo in the treatment of ADHD symptoms in adults.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: ORG 26576
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • The primary efficacy outcome measure is the change from baseline in weekly ADHD symptomatology score, assessed by the 18-point Adult ADHD Investigator Symptom Rating Scale (AISRS) [ Time Frame: Weekly up to 56 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluating treatment effects of Org 26576 compared to placebo to explore safety & tolerability, optimal dose for efficacy of Org 26576 in adult subjects with ADHD, onset of action, depressive symptom changes, cognitive function [ Time Frame: Weekly up to 56 days ] [ Designated as safety issue: Yes ]

Enrollment: 67
Study Start Date: April 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
100 mg Org 26576 or placebo BID
Drug: ORG 26576
three capsules BID
Drug: Placebo
Three capsules BID
Experimental: 2
Placebo or 100 mg Org 26576 BID
Drug: ORG 26576
three capsules BID
Drug: Placebo
Three capsules BID
Experimental: 3
100-300 mg Org 26576 or placeboBID
Drug: ORG 26576
three capsules BID
Drug: Placebo
Three capsules BID
Placebo Comparator: 4
Placebo or 100-300 mg Org 26576 BID
Drug: ORG 26576
three capsules BID
Drug: Placebo
Three capsules BID

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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 DSM-IV-TRTM
  • have a Clinical Global Impression ADHD score of four or higher at screening

Exclusion Criteria:

  • 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 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 (SGPT, SGOT,GGT, 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 IgM antibodies or hepatitis C total antibodies;
  • are pregnant as confirmed by a positive serum pregnancy test at screening;
  • have QTc values >450 milliseconds at screening using Fridericia's QTc formula; 10. 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; Psychiatric
  • 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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00610441     History of Changes
Other Study ID Numbers: P05805, 174007
Study First Received: January 28, 2008
Last Updated: September 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
randomized
double blind
placebo controlled

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014