NCT00150579

Brief Summary

The purpose of this study is to assess the safety and effectiveness of SPD465 compared to placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also look at how SPD465 affects sleep and how the participants perceive their quality of life.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

5 months

First QC Date

September 6, 2005

Last Update Submit

June 25, 2021

Conditions

Attention Deficit Disorder With Hyperactivity

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in the ADHD-rating scale 4th Edition (ADHD-RS-IV) total score to the Endpoint assessment.

    The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.

    Baseline, and the Endpoint (average of weeks 5, 6, 7).

Secondary Outcomes (7)

  • Change from Baseline in the Clinical Global Impression of Improvement scale (CGI-I) to the Endpoint assessment.

    Baseline, and the Endpoint (average of weeks 5, 6, 7).

  • Change from Baseline in the Time-Sensitive ADHD Symptom Scale (TASS) score to the Endpoint assessment.

    Baseline, and the Endpoint (average of weeks 5, 6, 7).

  • Change from Baseline in the Brown Attention Deficit Disorder Scale (BADDS) to the Endpoint assessment

    Baseline, and the Endpoint (average of weeks 5, 6, 7).

  • Change in Baseline in the Adult ADHD Impact Module (AIM-A) score to the Endpoint assessment

    Baseline, and the Endpoint (average of weeks 5, 6, 7).

  • Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 1

    Baseline and Week 1.

  • +2 more secondary outcomes

Interventions

Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrateDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primary diagnosis of ADHD
  • Baseline ADHD-RS-IV score \>= 24
  • Non-pregnant females of childbearing potential must comply with contraceptive restrictions

You may not qualify if:

  • Significantly underweight or morbidly obese
  • Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Axis I disorders
  • History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Surman CBH, Robertson B, Chen J, Cortese S. Post-Hoc Analyses of the Effects of Baseline Sleep Quality on SHP465 Mixed Amphetamine Salts Extended-Release Treatment Response in Adults with Attention-Deficit/Hyperactivity Disorder. CNS Drugs. 2019 Jul;33(7):695-706. doi: 10.1007/s40263-019-00645-z.

    PMID: 31228031DERIVED

  • Brown TE, Landgraf JM. Improvements in executive function correlate with enhanced performance and functioning and health-related quality of life: evidence from 2 large, double-blind, randomized, placebo-controlled trials in ADHD. Postgrad Med. 2010 Sep;122(5):42-51. doi: 10.3810/pgm.2010.09.2200.

    PMID: 20861587DERIVED

  • Spencer TJ, Landgraf JM, Adler LA, Weisler RH, Anderson CS, Youcha SH. Attention-deficit/hyperactivity disorder-specific quality of life with triple-bead mixed amphetamine salts (SPD465) in adults: results of a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2008 Nov;69(11):1766-75. doi: 10.4088/jcp.v69n1112. Epub 2008 Nov 4.

    PMID: 19026251DERIVED

  • Spencer TJ, Adler LA, Weisler RH, Youcha SH. Triple-bead mixed amphetamine salts (SPD465), a novel, enhanced extended-release amphetamine formulation for the treatment of adults with ADHD: a randomized, double-blind, multicenter, placebo-controlled study. J Clin Psychiatry. 2008 Sep;69(9):1437-48. doi: 10.4088/jcp.v69n0911. Epub 2008 Sep 9.

    PMID: 19012813DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

AmphetamineFumigant 93

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

January 27, 2005

Primary Completion

June 14, 2005

Study Completion

June 14, 2005

Last Updated

June 30, 2021

Record last verified: 2021-06