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A D1 Agonist For Working Memory

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ClinicalTrials.gov Identifier: NCT02507206
Recruitment Status : Completed
First Posted : July 23, 2015
Last Update Posted : April 9, 2018
Sponsor:
Collaborators:
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Antonia New, Icahn School of Medicine at Mount Sinai

Brief Summary:

The purpose of the study is to examine the effects of the administration of a drug called DAR-0100A on attention and memory in persons with schizotypal personality disorder (SPD). DAR-0100A has not been FDA approved, however in recent studies has been used to treat cognitive deficits, meaning problems in the way you organize your thinking, in people diagnosed with schizophrenia.

Many people who carry a diagnosis of schizotypal personality disorder have trouble with attention and memory. Increasing the presence of a brain chemical called dopamine has been found to help people with schizophrenia with their attention and memory problems. This study will investigate whether the same is true for people with schizotypal personality disorder by using DAR-0100A, a drug that has been shown to help with the cognitive deficits of people with Parkinson's disease by increasing dopamine effects. Information collected in this experiment may lead to a better understanding of the brain mechanisms involved in schizotypal personality disorder and improve treatments for the psychological problems associated with this condition.


Condition or disease Intervention/treatment Phase
Schizotypal Personality Disorder SPD Drug: DAR 0-100A Drug: Placebo Phase 2

Detailed Description:

Primary Aims:

  1. To perform a 5-year study in which three consecutive days of DAR-0100A at a dose of 15 mg or placebo are administered intravenously over 30 minutes to 60 patients with SPD (12/yr) in a between-groups, randomized, double-blind design. Cognitive testing will be performed at baseline (Visit 1) and on the third day of drug/placebo administration (Visit 4). Subjects will return a minimum of two weeks later for Visit 5 to receive drug (if randomized initially to placebo) or placebo (if randomized to drug) in a double blind fashion in an identical protocol. This allows all patients to receive drug for Secondary Aim 1 while maintaining the blind. Baseline (Visit 1) and repeat cognitive testing (Visit 4) is also administered to 60 healthy controls per year (12/yr). The cognitive tests of working memory serving as primary outcome measures will include the modified AX-CPT (accuracy scores for AX, AY and BX and ANOVA), the N-back (delta difference 0-back-2-back), and the Paced Auditory Serial Addition Task (PASAT) (% correct and ANOVA). Other tests included are tests of working and verbal memory, executive function, and verbal learning for secondary outcome measures as well as comparison tests not hypothesized to change with drug.
  2. To compare changes on the primary outcome measures from baseline to Visit 4 testing between drug and placebo administration in SPD subjects.
  3. To compare primary outcome variables from baseline to Visit 4 between patients groups and healthy controls.
  4. To obtain plasma DAR-0100A concentrations on Visit 4 to evaluate plasma concentrations in relation to cognitive changes as a potential covariate.

Secondary Aims:

  1. To evaluate the change between baseline and Visit 4 cognitive testing in all SPD patients receiving drug in the first or second phase.
  2. To evaluate secondary outcome and comparison variables between SPD patients on placebo and drug.

Primary Hypotheses:

1. Baseline primary outcome measures will be impaired in 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 between baseline and Visit 4.

3. SPD patients will show significant improvements on primary outcome variables on drug compared to placebo but not on comparis-on perceptual (JLOT) and processing speed/attentional tasks (Trails A).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A D1 Agonist For Working Memory Enhancement In The Schizophrenia Spectrum
Study Start Date : April 2013
Actual Primary Completion Date : January 12, 2018
Actual Study Completion Date : January 12, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DAR 0-100A then Placebo
15 mg is dissolved in 150 cc NS administered over 30 minutes x 3 consecutive days. Subjects will return a minimum of two weeks later for Visit 5 to receive drug (if randomized initially to placebo) or placebo (if randomized to drug).
Drug: DAR 0-100A
15 mg DAR 0100A is dissolved in 150 cc NS administered over 30 minutes intravenously.
Other Names:
  • DHX
  • dihydrexidine

Drug: Placebo
15 mg DAR placebo is dissolved in 150 cc NS administered over 30 minutes intravenously.

Placebo Comparator: Placebo then DAR 0-100A
15 mg dissolved in 150 cc NS saline is administered over 30 minutes x 3 consecutive days. Subjects will return a minimum of two weeks later for Visit 5 to receive drug (if randomized initially to placebo) or placebo (if randomized to drug).
Drug: DAR 0-100A
15 mg DAR 0100A is dissolved in 150 cc NS administered over 30 minutes intravenously.
Other Names:
  • DHX
  • dihydrexidine

Drug: Placebo
15 mg DAR placebo is dissolved in 150 cc NS administered over 30 minutes intravenously.

No Intervention: Healthy Control
patients without diagnosis of SPD



Primary Outcome Measures :
  1. The Modified AX-CPT (d') [ Time Frame: Baseline performance ]
    A cognitive test of working memory


Secondary Outcome Measures :
  1. The Modified AX-CPT (d') [ Time Frame: Day one ]
    A cognitive test of working memory

  2. The Modified AX-CPT (d') [ Time Frame: Day three ]
    A cognitive test of working memory

  3. The Modified AX-CPT (d') [ Time Frame: One month ]
    A cognitive test of working memory


Other Outcome Measures:
  1. the N-Back [ Time Frame: Baseline ]
    A cognitive tests of working memory - the N-Back (% correct at the 2-back condition)

  2. the N-Back [ Time Frame: Day one ]
    A cognitive tests of working memory - the N-Back (% correct at the 2-back condition)

  3. the N-Back [ Time Frame: Day three ]
    A cognitive tests of working memory - the N-Back (% correct at the 2-back condition)

  4. the N-Back [ Time Frame: One month ]
    A cognitive tests of working memory - the N-Back (% correct at the 2-back condition)

  5. the DOT Task [ Time Frame: Baseline ]
    A cognitive tests of working memory - the DOT Task (distance error at 30 second delay--no delay)

  6. the DOT Task [ Time Frame: Day one ]
    A cognitive tests of working memory - the DOT Task (distance error at 30 second delay--no delay)

  7. the DOT Task [ Time Frame: Day three ]
    A cognitive tests of working memory - the DOT Task (distance error at 30 second delay--no delay)

  8. the DOT Task [ Time Frame: One month ]
    A cognitive tests of working memory - the DOT Task (distance error at 30 second delay--no delay)

  9. the Paced Auditory Serial Addition Task (PASAT) [ Time Frame: Baseline ]
    A cognitive tests of working memory - the Paced Auditory Serial Addition Task

  10. the Paced Auditory Serial Addition Task (PASAT) [ Time Frame: Day one ]
    A cognitive tests of working memory - the Paced Auditory Serial Addition Task

  11. the Paced Auditory Serial Addition Task (PASAT) [ Time Frame: Day three ]
    A cognitive tests of working memory - the Paced Auditory Serial Addition Task

  12. the Paced Auditory Serial Addition Task (PASAT) [ Time Frame: One month ]
    A cognitive tests of working memory - the Paced Auditory Serial Addition Task



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Currently meeting DSM-IV-TR criteria for Schizotypal
  • Personality Disorder
  • Males and Females 18 ≤ age ≤ 65
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507206


Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Antonia New
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Antonia S. New, MD Icahn School of Medicine at Mount Sinai

Publications:
Responsible Party: Antonia New, Professor of Psychiatry and Director of Medical Student Education, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02507206     History of Changes
Other Study ID Numbers: GCO 11-1279
5R01MH097799-02 ( U.S. NIH Grant/Contract )
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018

Keywords provided by Antonia New, Icahn School of Medicine at Mount Sinai:
schizotypal personality disorder
cognitive impairment
working memory
Dopamine Agonists
Cognition Disorders
Personality Disorders
Delirium
Dementia
Amnestic
Cognitive Disorders
Mental Disorders
Dihydrexidine
Dopamine A

Additional relevant MeSH terms:
Personality Disorders
Schizotypal Personality Disorder
Mental Disorders
Dopamine
Dihydrexidine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Dopamine Agonists