Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Clinical Testing of a D1 Agonist for Cognitive Enhancement in Schizotypal Personality Disorder (SPD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Mount Sinai School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
New York State Psychiatric Institute
Information provided by (Responsible Party):
Larry J. Siever, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01466205
First received: October 27, 2011
Last updated: July 19, 2012
Last verified: July 2012
  Purpose

Currently, no study to date has directly tested a selective D1R agonist in relation to the cognitive impairment of Schizophrenia without the confound of neuroleptics. The investigators propose to examine the efficacy of DAR-0100A, a highly selective, full D1R agonist supported by pre-clinical and preliminary pilot clinical data, in ameliorating the cognitive deficits in Schizotypal Personality Disordered subjects receiving no medications including antipsychotics.

The investigators hypothesize that 1) Baseline primary outcome measures will be impaired in Schizotypal personality disorder (SPD) subjects compared to controls, 2) SPD subjects on DAR-0100A will show improvement on primary measures greater than healthy controls and SPD patients randomized to placebo, and 3) SPD patients will show significant improvements on primary outcome variables on drug compared to placebo.


Condition Intervention Phase
Cognitive Impairments
Schizotypal Personality Disorder
Drug: DAR-0100A
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Testing of a D1 Agonist for Cognitive Enhancement in Schizotypal Personality Disorder

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Efficacy of a D1 Agonist for Cognitive Enhancement of Working Memory in Schizotypal Personality Disorder [ Time Frame: Baseline performance ] [ Designated as safety issue: No ]
    The cognitive tests of working memory serving as primary outcome measures will include the modified AX-CPT (d'), the N-Back (% correct at the 2-back condition), the DOT Task (distance error at 30 second delay--no delay), and the Paced Auditory Serial Addition Task (PASAT)(correct responses).

  • Efficacy of a D1 Agonist for Cognitive Enhancement of Working Memory in Schizotypal Personality Disorder [ Time Frame: day one of drug administration ] [ Designated as safety issue: No ]
    The cognitive tests of working memory serving as primary outcome measures will include the modified AX-CPT (d'), the N-Back (% correct at the 2-back condition), the DOT Task (distance error at 30 second delay--no delay), and the Paced Auditory Serial Addition Task (PASAT)(correct responses).

  • Efficacy of a D1 Agonist for Cognitive Enhancement of Working Memory in Schizotypal Personality Disorder [ Time Frame: after three days of drug administration ] [ Designated as safety issue: No ]
    The cognitive tests of working memory serving as primary outcome measures will include the modified AX-CPT (d'), the N-Back (% correct at the 2-back condition), the DOT Task (distance error at 30 second delay--no delay), and the Paced Auditory Serial Addition Task (PASAT)(correct responses).

  • Efficacy of a D1 Agonist for Cognitive Enhancement of Working Memory in Schizotypal Personality Disorder [ Time Frame: one month after drug administration ] [ Designated as safety issue: No ]
    The cognitive tests of working memory serving as primary outcome measures will include the modified AX-CPT (d'), the N-Back (% correct at the 2-back condition), the DOT Task (distance error at 30 second delay--no delay), and the Paced Auditory Serial Addition Task (PASAT)(correct responses).


Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DAR 0-100A
The examination of SPD subjects, who are more likely than schizophrenia patients to show significant cognitive improvement after the use of single doses of dopamine agonists, such as DAR-0100A provides an excellent opportunity to demonstrate the effectiveness of D1 agonists on cognition in the schizophrenia spectrum.
Drug: DAR-0100A
DAR-0100A will be administered intravenously in a dose of 15mg in 150mls of saline over 30 minutes at approximately 11:00AM on each of three consecutive days of administration. Additional saline will be co-administered to ensure hydration.
Placebo Comparator: Placebo
Some subjects receive placebo, instead of the study drug, in a double-blind randomized fashion. This allows for performance comparison between SPD subjects on DAR-0100A and those on placebo. The hypothesis is that SPD subjects on DAR-100A will show improvement on primary measures greater than SPD subjects randomized to placebo between baseline and post-drug.
Drug: Placebo
150mls of saline is administered over 30 minutes at approximately 11:00AM on each of three consecutive days of administration. Additional saline will be co-administered to ensure hydration.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently meeting DSM-IV-TR criteria for Schizotypal Personality Disorder
  • Males and Females 18 ≤ age ≤ 60
  • Medically and neurologically healthy
  • Willing and having capacity to provide informed consent

Exclusion Criteria:

  • Currently bipolar I disorder, schizophrenia or current psychosis
  • Clinically significant cardiovascular or neurological conditions, uncontrolled hypertension, clinically significant EKG abnormalities, or serious general medical illness
  • Clinical evidence of dehydration or significant hypotension
  • Currently meeting DSM-IV-TR criteria for Major Depressive Disorder
  • Current substance abuse or past dependence within the last six months (other than nicotine)
  • Currently taking psychotropic medications
  • Currently pregnant or lactating
  • Non-English speaking

Socio-economically disadvantaged people will be included in our research study.

  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466205

Contacts
Contact: Lauren C Zaluda, BA 2122410441 ext 40442 lauren.zaluda@mssm.edu
Contact: Yosefa A Ehrlich, BA 2122412190 ext 42190 yosefa.ehrlich@mssm.edu

Locations
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Principal Investigator: Larry J Siever, MD         
Sponsors and Collaborators
Larry J. Siever
New York State Psychiatric Institute
Investigators
Principal Investigator: Larry J Siever, MD Mount Sinai School of Medicine
Principal Investigator: Larry Siever, MD James J Peters Bronx VA Hospital
  More Information

No publications provided

Responsible Party: Larry J. Siever, Executive Director, Mental Illness Research Education and Clinical Center (MIRECC); Chief, Psychiatry Program, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01466205     History of Changes
Other Study ID Numbers: 11-0110
Study First Received: October 27, 2011
Last Updated: July 19, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
schizotypal personality disorder
cognitive impairment
working memory

Additional relevant MeSH terms:
Cognition Disorders
Disease
Personality Disorders
Schizotypal Personality Disorder
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Pathologic Processes
Dihydrexidine
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014