NCT02507206

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2013

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

April 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2018

Completed
Last Updated

April 9, 2018

Status Verified

April 1, 2018

Enrollment Period

4.8 years

First QC Date

July 22, 2015

Last Update Submit

April 5, 2018

Conditions

Schizotypal Personality DisorderSPD

Keywords

schizotypal personality disordercognitive impairmentworking memoryDopamine AgonistsCognition DisordersPersonality DisordersDeliriumDementiaAmnesticCognitive DisordersMental DisordersDihydrexidineDopamine A

Outcome Measures

Primary Outcomes (1)

  • The Modified AX-CPT (d')

    A cognitive test of working memory

    Baseline performance

Secondary Outcomes (3)

  • The Modified AX-CPT (d')

    Day one

  • The Modified AX-CPT (d')

    Day three

  • The Modified AX-CPT (d')

    One month

Other Outcomes (12)

  • the N-Back

    Baseline

  • the N-Back

    Day one

  • the N-Back

    Day three

  • +9 more other outcomes

Study Arms (3)

DAR 0-100A then Placebo

EXPERIMENTAL

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 0-100ADrug: Placebo

Placebo then DAR 0-100A

PLACEBO COMPARATOR

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 0-100ADrug: Placebo

Healthy Control

NO INTERVENTION

patients without diagnosis of SPD

Interventions

DAR 0-100ADRUG

15 mg DAR 0100A is dissolved in 150 cc NS administered over 30 minutes intravenously.

Also known as: DHX, dihydrexidine
DAR 0-100A then PlaceboPlacebo then DAR 0-100A
PlaceboDRUG

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

DAR 0-100A then PlaceboPlacebo then DAR 0-100A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (6)

  • Arnsten AF, Cai JX, Murphy BL, Goldman-Rakic PS. Dopamine D1 receptor mechanisms in the cognitive performance of young adult and aged monkeys. Psychopharmacology (Berl). 1994 Oct;116(2):143-51. doi: 10.1007/BF02245056.

    PMID: 7862943BACKGROUND

  • Abi-Dargham A. Probing cortical dopamine function in schizophrenia: what can D1 receptors tell us? World Psychiatry. 2003 Oct;2(3):166-71.

    PMID: 16946930BACKGROUND

  • Castner SA, Williams GV, Goldman-Rakic PS. Reversal of antipsychotic-induced working memory deficits by short-term dopamine D1 receptor stimulation. Science. 2000 Mar 17;287(5460):2020-2. doi: 10.1126/science.287.5460.2020.

    PMID: 10720329BACKGROUND

  • Fici GJ, Wu H, VonVoigtlander PF, Sethy VH. D1 dopamine receptor activity of anti-parkinsonian drugs. Life Sci. 1997;60(18):1597-603. doi: 10.1016/s0024-3205(97)00126-4.

    PMID: 9126882BACKGROUND

  • Kirrane RM, Mitropoulou V, Nunn M, New AS, Harvey PD, Schopick F, Silverman J, Siever LJ. Effects of amphetamine on visuospatial working memory performance in schizophrenia spectrum personality disorder. Neuropsychopharmacology. 2000 Jan;22(1):14-8. doi: 10.1016/S0893-133X(99)00075-5.

    PMID: 10633486BACKGROUND

  • Koenigsberg HW, Reynolds D, Goodman M, New AS, Mitropoulou V, Trestman RL, Silverman J, Siever LJ. Risperidone in the treatment of schizotypal personality disorder. J Clin Psychiatry. 2003 Jun;64(6):628-34. doi: 10.4088/jcp.v64n0602.

    PMID: 12823075BACKGROUND

MeSH Terms

Conditions

Schizotypal Personality DisorderCognitive DysfunctionCognition DisordersPersonality DisordersDeliriumDementiaMental Disorders

Interventions

dihydrexidine

Condition Hierarchy (Ancestors)

Neurocognitive DisordersConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Antonia S. New, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Psychiatry and Director of Medical Student Education

Study Record Dates

First Submitted

July 22, 2015

First Posted

July 23, 2015

Study Start

April 1, 2013

Primary Completion

January 12, 2018

Study Completion

January 12, 2018

Last Updated

April 9, 2018

Record last verified: 2018-04

Locations

US(1)