Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacology of Cognition in Schizotypal Personality Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00353379
Recruitment Status : Terminated (low enrollment)
First Posted : July 18, 2006
Last Update Posted : February 10, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE July 14, 2006
First Posted Date  ICMJE July 18, 2006
Last Update Posted Date February 10, 2017
Actual Study Start Date  ICMJE September 1995
Actual Primary Completion Date May 1997   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2012)
  • Performance on tests of sustained attention, episodic memory, and working memory [ Time Frame: Measured at Week 1 ]
  • Performance on tests of sustained attention, episodic memory, and working memory [ Time Frame: Measured at Week 4 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 14, 2006)
Performance on tests of sustained attention, episodic memory, and working memory (measured at Week 8)
Change History Complete list of historical versions of study NCT00353379 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2012)
  • Hamilton Depression Rating Scale [ Time Frame: Measured at Week 1 ]
  • Hamilton Depression Rating Scale [ Time Frame: Measured at Week 2 ]
  • Hamilton Depression Rating Scale [ Time Frame: Measured at Week 3 ]
  • Hamilton Depression Rating Scale [ Time Frame: Measured at Week 4 ]
  • Hamilton Depression Rating Scale [ Time Frame: Measured at Week 5 ]
  • Positive and Negative Symptom Scale [ Time Frame: Measured at Week 1 ]
  • Positive and Negative Symptom Scale [ Time Frame: Measured at Week 2 ]
  • Positive and Negative Symptom Scale [ Time Frame: Measured at Week 3 ]
  • Positive and Negative Symptom Scale [ Time Frame: Measured at Week 4 ]
  • Positive and Negative Symptom Scale [ Time Frame: Measured at Week 5 ]
  • Clinical Global Impression Scale [ Time Frame: Measured at Week 1 ]
  • Clinical Global Impression Scale [ Time Frame: Measured at Week 2 ]
  • Clinical Global Impression Scale [ Time Frame: Measured at Week 3 ]
  • Clinical Global Impression Scale [ Time Frame: Measured at Week 4 ]
  • Clinical Global Impression Scale [ Time Frame: Measured at Week 5 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2006)
  • Hamilton Depression Rating Scale
  • Positive and Negative Symptom Scale
  • Clinical Global Impression Scale (all measured at Week 8)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacology of Cognition in Schizotypal Personality Disorder
Official Title  ICMJE Pharmacology of Cognition in Schizotypal Personality Disorder: Guanfacine for Cognitive Symptoms in Schizotypal Personality Disorder
Brief Summary This study will determine the effectiveness of guanfacine in improving cognitive and functional impairments in schizotypal personality disorder.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizotypal Personality Disorder
  • Personality Disorders
Intervention  ICMJE
  • Drug: Guanfacine
    Participants will take guanfacine for 6 weeks. Guanfacine dosages will not exceed 2 mg per day.
  • Drug: Placebo
    Participants will take placebo for 6 weeks.
Study Arms  ICMJE
  • Experimental: guanfacine
    Participants will take guanfacine.
    Intervention: Drug: Guanfacine
  • Placebo Comparator: placebo
    Participants will take placebo.
    Intervention: Drug: Placebo
Publications * 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. Epub 2006 Sep 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 9, 2017)
29
Original Enrollment  ICMJE
 (submitted: July 14, 2006)
80
Actual Study Completion Date  ICMJE May 1997
Actual Primary Completion Date May 1997   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00353379
Other Study ID Numbers  ICMJE GCO 95-0650
R01MH056140 ( U.S. NIH Grant/Contract )
DATR A3-NSS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Larry J. Siever, MD Bronx VA Medical Center/Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP