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

NCT01466205 | Unknown Phase 2 DMC

• 1 other identifier: 11-0110
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Impairments; Schizotypal Personality Disorder

Keywords

schizotypal personality disorder; cognitive impairment; working memory

Outcome Measures

Primary Outcomes (4)

• Efficacy of a D1 Agonist for Cognitive Enhancement of Working Memory in Schizotypal Personality Disorder

  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).

  Baseline performance

• Efficacy of a D1 Agonist for Cognitive Enhancement of Working Memory in Schizotypal Personality Disorder

  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).

  day one of drug administration

• Efficacy of a D1 Agonist for Cognitive Enhancement of Working Memory in Schizotypal Personality Disorder

  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).

  after three days of drug administration

• Efficacy of a D1 Agonist for Cognitive Enhancement of Working Memory in Schizotypal Personality Disorder

  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).

  one month after drug administration

Study Arms (2)

DAR 0-100A

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

DAR-0100A DRUG

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.

DAR 0-100A

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Larry J. Siever: lead
• New York State Psychiatric Institute: collaborator

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Schizotypal Personality Disorder

Interventions

dihydrexidine

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Personality Disorders

Study Officials

• Larry J Siever, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Larry Siever, MD

  James J Peters Bronx VA Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren C Zaluda, BA

CONTACT

2122410441; lauren.zaluda@mssm.edu

Yosefa A Ehrlich, BA

CONTACT

2122412190; yosefa.ehrlich@mssm.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Director, Mental Illness Research Education and Clinical Center (MIRECC); Chief, Psychiatry Program

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: November 7, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: July 20, 2012

Record last verified: 2012-07

Locations

US (1)