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Schizotypal Personality DisorderPhase 4NCT00353379

Pharmacology of Cognition in Schizotypal Personality Disorder

A Phase 4 study testing Guanfacine in people with Schizotypal Personality Disorder and Personality Disorders, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
Guanfacine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
29 participants
Where
1 siteUnited States
Study dates
Sep 1995to May 1997
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • Healthy Controls:
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

Official title: Pharmacology of Cognition in Schizotypal Personality Disorder: Guanfacine for Cognitive Symptoms in Schizotypal Personality Disorder

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

Read the 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.

Being tested
Guanfacine, Placebo
Medical subject headings
Schizotypal Personality Disorder, Personality Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GuanfacineDrug

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

  • PlaceboDrug

    Participants will take placebo for 6 weeks.

Study groups in NCT00353379
Study groupRoleWhat they receive
guanfacineExperimentalParticipants will take guanfacine.
Receives: Drug: Guanfacine
placeboPlacebo comparatorParticipants will take placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Performance on tests of sustained attention, episodic memory, and working memory

    Measured: Measured at Week 1

  2. Performance on tests of sustained attention, episodic memory, and working memory

    Measured: Measured at Week 4

Secondary outcomes (15)

  1. Hamilton Depression Rating Scale

    Measured: Measured at Week 1

  2. Hamilton Depression Rating Scale

    Measured: Measured at Week 2

  3. Hamilton Depression Rating Scale

    Measured: Measured at Week 3

  4. Hamilton Depression Rating Scale

    Measured: Measured at Week 4

  5. Hamilton Depression Rating Scale

    Measured: Measured at Week 5

  6. Positive and Negative Symptom Scale

    Measured: Measured at Week 1

  7. Positive and Negative Symptom Scale

    Measured: Measured at Week 2

  8. Positive and Negative Symptom Scale

    Measured: Measured at Week 3

  9. Positive and Negative Symptom Scale

    Measured: Measured at Week 4

  10. Positive and Negative Symptom Scale

    Measured: Measured at Week 5

  11. Clinical Global Impression Scale

    Measured: Measured at Week 1

  12. Clinical Global Impression Scale

    Measured: Measured at Week 2

  13. Clinical Global Impression Scale

    Measured: Measured at Week 3

  14. Clinical Global Impression Scale

    Measured: Measured at Week 4

  15. Clinical Global Impression Scale

    Measured: Measured at Week 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2006 (estimated)
  2. Study startSep 1995
  3. Primary completionMay 1997
  4. Study completionMay 1997

Why it stopped: low enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00353379
Sponsor's protocol ID
GCO 95-0650
Other IDs
R01MH056140, DATR A3-NSS
Status last verified
Feb 2017
First submitted
14 Jul 2006
Last updated
10 Feb 2017
Results posted
No
Data monitoring committee
Yes

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. doi: 10.1016/j.biopsych.2006.06.034. Epub 2006 Sep 1.

    PubMed 16950221

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Guanfacine in people with Schizotypal Personality Disorder and Personality Disorders, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: low enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance on tests of sustained attention, episodic memory, and working memory (time frame: Measured at Week 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00353379, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.

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