Dose Finding Study in Adults With Attention Deficit Hyperactivity Disorder (ADHD)(174007)(COMPLETED)(P05805)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00610441
First received: January 28, 2008
Last updated: January 30, 2013
Last verified: January 2013
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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 Schering-Plough:
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
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00610441 History of Changes |
| Other Study ID Numbers: | 174007, P05805 |
| Study First Received: | January 28, 2008 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Schering-Plough:
|
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 May 23, 2013