Pharmacology of Cognition in Schizotypal Personality Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Mount Sinai School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Larry J. Siever, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00353379
First received: July 14, 2006
Last updated: July 19, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
Schizotypal Personality Disorder
Personality Disorders
Drug: Guanfacine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pharmacology of Cognition in Schizotypal Personality Disorder: Guanfacine for Cognitive Symptoms in Schizotypal Personality Disorder

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Performance on tests of sustained attention, episodic memory, and working memory [ Time Frame: Measured at Week 1 ] [ Designated as safety issue: No ]
  • Performance on tests of sustained attention, episodic memory, and working memory [ Time Frame: Measured at Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hamilton Depression Rating Scale [ Time Frame: Measured at Week 1 ] [ Designated as safety issue: No ]
  • Hamilton Depression Rating Scale [ Time Frame: Measured at Week 2 ] [ Designated as safety issue: No ]
  • Hamilton Depression Rating Scale [ Time Frame: Measured at Week 3 ] [ Designated as safety issue: No ]
  • Hamilton Depression Rating Scale [ Time Frame: Measured at Week 4 ] [ Designated as safety issue: No ]
  • Hamilton Depression Rating Scale [ Time Frame: Measured at Week 5 ] [ Designated as safety issue: No ]
  • Positive and Negative Symptom Scale [ Time Frame: Measured at Week 1 ] [ Designated as safety issue: No ]
  • Positive and Negative Symptom Scale [ Time Frame: Measured at Week 2 ] [ Designated as safety issue: No ]
  • Positive and Negative Symptom Scale [ Time Frame: Measured at Week 3 ] [ Designated as safety issue: No ]
  • Positive and Negative Symptom Scale [ Time Frame: Measured at Week 4 ] [ Designated as safety issue: No ]
  • Positive and Negative Symptom Scale [ Time Frame: Measured at Week 5 ] [ Designated as safety issue: No ]
  • Clinical Global Impression Scale [ Time Frame: Measured at Week 1 ] [ Designated as safety issue: No ]
  • Clinical Global Impression Scale [ Time Frame: Measured at Week 2 ] [ Designated as safety issue: No ]
  • Clinical Global Impression Scale [ Time Frame: Measured at Week 3 ] [ Designated as safety issue: No ]
  • Clinical Global Impression Scale [ Time Frame: Measured at Week 4 ] [ Designated as safety issue: No ]
  • Clinical Global Impression Scale [ Time Frame: Measured at Week 5 ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: September 2007
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: guanfacine
Participants will take guanfacine.
Drug: Guanfacine
Participants will take guanfacine for 6 weeks. Guanfacine dosages will not exceed 2 mg per day.
Placebo Comparator: placebo
Participants will take placebo.
Drug: Placebo
Participants will take placebo for 6 weeks.

Detailed Description:

Schizotypal personality disorder is a psychiatric condition that is characterized by deficiencies in interpersonal relationships and disturbances in thought patterns, appearance, and behavior. This disorder is different from schizophrenia. While some of the symptoms of the two disorders are similar, such as the tendency to have unusual beliefs and behaviors, people with schizotypal personality disorder do not experience hallucinations and are not significantly disconnected from reality, both of which are signature symptoms of schizophrenia. Guanfacine is a drug that is often used to treat high blood pressure and attention deficit hyperactivity disorder. There is evidence that guanfacine enhances cognition and diminishes impulsivity. This study will determine the effectiveness of guanfacine in improving symptoms of schizotypal personality disorder.

Participants in this 6-week, double-blind study will be randomly assigned to receive either guanfacine or placebo. Participants receiving guanfacine will remain on the drug for the duration of the study. The other participants will receive placebo for the duration of the study. Guanfacine dosages will not exceed 2 mg per day. All participants will report to the study site weekly for assessments of vital signs, study compliance, medication side effects, and psychological symptoms. Additional cognitive testing will be performed at week 6. Upon study completion, patients will return for a follow-up assessment.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • Any cardiovascular condition that, based on the research clinician's judgment (which includes cardiological consultation), would put the participant at increased risk will be considered an exclusion criteria. This would certainly include evidence by history or exam of heart block, tachyarrhythmia, angina, ventricular hypertrophy, those taking antihypertensives. Blood pressure parameters will be a >25% decrease in mean arterial systolic blood pressure from baseline, an orthostatic decrease in systolic blood pressure of 20 mm Hg and/or in diastolic blood pressure of 10 mm Hg, and heart rate parameter will be below 55 bpm.
  • 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:

Inclusion Criteria:

  • 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.

Exclusion criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353379

Contacts
Contact: Yosefa E Ehrlich, BA 2122412190 ext 42190 yosefa.ehrlich@mssm.edu
Contact: Lauren C Zaluda, BA 2122410442 ext 40442 lauren.zaluda@mssm.edu

Locations
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Larry J. Siever, MD Bronx VA Medical Center/Mount Sinai School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Larry J. Siever, Professor, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00353379     History of Changes
Other Study ID Numbers: 95-650, R01MH056140, DATR A3-NSS
Study First Received: July 14, 2006
Last Updated: July 19, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Personality Disorders
Schizotypal Personality Disorder
Mental Disorders
Guanfacine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014