NCT00252044

Brief Summary

Hypothesis: Schizotypal personality disorder patients will show cognitive improvements in 1) working memory 2) learning and memory 3) sustained attention 4) enhanced performance on the AX-CPT, N-back and Eriksen during pergolide treatment. There will be a significant diagnosis by drug administration of 0.3 mg of oral pergolide interaction for performance on the cognitive tasks, with the schizotypal personality disorder group demonstrating significantly improved peformance compared to the other personality disorder group after pergolide compared with placebo. Design: Randomized, double-blind, crossover study of pergolide vs. placebo. Half of subjects receive pergolide for eight weeks; half of subjects receive placebo for four weeks followed by pergolide for four weeks.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2005

Completed
Last Updated

November 21, 2005

Status Verified

November 1, 2005

First QC Date

November 9, 2005

Last Update Submit

November 17, 2005

Conditions

Schizotypal Personality DisorderOther Personality Disorders

Outcome Measures

Primary Outcomes (1)

  • Performance on tests of sustained attention, episodic memory and working memory at baseline and after 2, 4, 6 and 8 weeks on the study medication

Secondary Outcomes (1)

  • Hamilton Depression Rating Scale, Positive and Negative Symptom Scale and Clinical Global Impression scale at baseline and then weekly through the end of the trial

Interventions

PergolideDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Schizotypal Personality Disorder

Interventions

Pergolide

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ErgolinesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Study Officials

  • Larry J Siever, MD

    Bronx VA Medical Center/Mount Sinai School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Hart

CONTACT

212-241-0441mpgroup@mssm.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
FED

Study Record Dates

First Submitted

November 9, 2005

First Posted

November 11, 2005

Study Start

October 1, 2000

Last Updated

November 21, 2005

Record last verified: 2005-11

Locations

US(1)