NCT00353379

Brief Summary

This study will determine the effectiveness of guanfacine in improving cognitive and functional impairments in schizotypal personality disorder.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 1995

Geographic Reach
1 country

1 active site

Status
terminated

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

September 1, 1995

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 1997

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 1997

Completed
9.2 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2006

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

1.7 years

First QC Date

July 14, 2006

Last Update Submit

February 9, 2017

Conditions

Schizotypal Personality DisorderPersonality Disorders

Outcome Measures

Primary Outcomes (2)

  • Performance on tests of sustained attention, episodic memory, and working memory

    Measured at Week 1

  • Performance on tests of sustained attention, episodic memory, and working memory

    Measured at Week 4

Secondary Outcomes (15)

  • Hamilton Depression Rating Scale

    Measured at Week 1

  • Hamilton Depression Rating Scale

    Measured at Week 2

  • Hamilton Depression Rating Scale

    Measured at Week 3

  • Hamilton Depression Rating Scale

    Measured at Week 4

  • Hamilton Depression Rating Scale

    Measured at Week 5

  • +10 more secondary outcomes

Study Arms (2)

guanfacine

EXPERIMENTAL

Participants will take guanfacine.

Drug: Guanfacine

placebo

PLACEBO COMPARATOR

Participants will take placebo.

Drug: Placebo

Interventions

GuanfacineDRUG

Participants will take guanfacine for 6 weeks. Guanfacine dosages will not exceed 2 mg per day.

guanfacine
PlaceboDRUG

Participants will take placebo for 6 weeks.

placebo

Eligibility Criteria

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

You may qualify if:

  • Subjects must be male or female
  • Medically and neurologically healthy (Medically healthy means that the patient does not have a major or partially treated medical condition that based on the judgment of the research clinician would either put the patient at increased risk and/or affect our findings. Common conditions include: high blood pressure, diabetes, uncontrolled asthma or COPD, abnormal heart rhythm, chronic viral infections. Neurologically healthy means that the patient has not experienced brain injury or head trauma associated with prolonged (e.g., \> 10 minutes) loss of consciousness, seizures or other conditions based on the research clinician's judgment would either put the patient at increased risk and/or affect our findings.)
  • Between 18 and 60 years of age
  • Patients must also be medication free (at least 2 weeks) while participating in guanfacine, except for the following medications: NSAIDS (eg, Advil), Tylenol, Levothyroxine (if on stable dose for 1 month, no symptoms of hypothyroidism and normal thyroid labs), Non-centrally acting antihistamines, H2 blockers (eg, Zantac), PPIs (eg, Prilosec, Prevacid). Research physician will make judgment on case-by-case basis based on risk to subject, and potential confounding effect on data validity.
  • Subjects in the SPD group must meet DSM-IV criteria for Schizotypal Personality Disorder.
  • Subjects in the AvPD group must meet DSM-IV criteria for Avoidant Personality Disorder and not meet criteria for schizotypal, paranoid, and schizoid personality disorder. In addition, the AvPD group must have fewer than 2 schizotypal traits.

You may not qualify if:

  • Subjects may not have a significant medical illness (ie, insulin dependent diabetes, gastric/duodenal ulcer), or significant neurological illness (ie epilepsy, CMS, CVA, focal neurological lesion).
  • Participants are also excluded if they are more than 40% above ideal body weight. The weight limit helps insure that standard doses of guanfacine will not be given to patients who are extremely overweight who might then receive a lower concentration of these drugs in their central nervous system.
  • Subjects must also have a corrected or uncorrected visual acuity of 20/40 or better.
  • All participants meeting DSM IV criteria for any current or past history of sustained IV-substance dependence are excluded from the study.
  • Participants must be free of substance abuse for at least six months.
  • Healthy Controls:
  • Healthy control subjects will be selected according to criteria noted in methods, and in age distribution comparable to our patients.
  • Healthy controls will be matched to patients on gender and parental socioeconomic status.
  • Healthy controls must be male or female between the ages of 18 and 60.
  • for medical illness are identical to those of patients
  • must not meet criteria for a current or lifetime DSM-IV diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or any Axis II disorder.
  • a current Axis I or II diagnosis or a family history of psychotic disorder will also be excluded. However, to avoid a group of HC's too highly groomed and unrepresentative of the general population we will not exclude HC subjects meeting criteria for a past Axis I diagnosis, such as adjustment disorder, dysthymic disorder, depressive disorder not otherwise specified, specific phobia, and sleep disorders. In addition subjects meeting criteria for a non-IV substance abuse disorder more than 6 months prior to enrollment will not be excluded.

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 (1)

  • McClure MM, Barch DM, Romero MJ, Minzenberg MJ, Triebwasser J, Harvey PD, Siever LJ. The effects of guanfacine on context processing abnormalities in schizotypal personality disorder. Biol Psychiatry. 2007 May 15;61(10):1157-60. doi: 10.1016/j.biopsych.2006.06.034. Epub 2006 Sep 1.

    PMID: 16950221RESULT

MeSH Terms

Conditions

Schizotypal Personality DisorderPersonality Disorders

Interventions

Guanfacine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsPhenylacetatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • Larry J. Siever, MD

    Bronx VA Medical Center/Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2006

First Posted

July 18, 2006

Study Start

September 1, 1995

Primary Completion

May 1, 1997

Study Completion

May 1, 1997

Last Updated

February 10, 2017

Record last verified: 2017-02

Locations

US(1)