Efficacy of Pimozide Augmentation for Clozapine Partial Response

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Handan Gunduz-Bruce, Yale University
ClinicalTrials.gov Identifier:
NCT00374244
First received: September 7, 2006
Last updated: April 26, 2012
Last verified: January 2012

September 7, 2006
April 26, 2012
January 2004
June 2011   (final data collection date for primary outcome measure)
  • Brief Psychiatric Rating Scale (BPRS) [ Time Frame: baseline and monthly ] [ Designated as safety issue: No ]
  • Scale for the Assessment of Negative Symptoms (SANS) [ Time Frame: baseline and monthly ] [ Designated as safety issue: No ]
  • Brief Psychiatric Rating Scale (BPRS)
  • Scale for the Assessment of Negative Symptoms (SANS)
Complete list of historical versions of study NCT00374244 on ClinicalTrials.gov Archive Site
  • Clinical Global Impression (CGI) [ Time Frame: Baseline and monthly ] [ Designated as safety issue: No ]
  • Brief neurocognitive battery [ Time Frame: Baseline and monthly ] [ Designated as safety issue: No ]
  • QTC changes [ Time Frame: Baseline and weekly ] [ Designated as safety issue: Yes ]
  • Structured Clinical Interview for Axis I DSM-IV Disorders (SCID DSM-IV)
  • Socioeconomic status (SES)
  • Clinical Global Impression (CGI)
  • Schedule for the Deficit Syndrome
  • Straus Carpenter Levels of Function
  • Modified Barnes Akathisia Scale
  • Simpson-Angus Scale for extrapyramidal symptoms (EPS)
  • Abnormal Involuntary Movement Scale (AIMS)
  • Plasma prolactin level
  • Weight
  • Weekly occurrence form
  • Brief neurocognitive battery
Not Provided
Not Provided
 
Efficacy of Pimozide Augmentation for Clozapine Partial Response
Efficacy of Pimozide Augmentation for Clozapine Partial Response

This is a 12 week outpatient study for patients with schizophrenia who are on Clozapine, but continue to experience symptoms. The purpose of this project is to find out if small doses of pimozide (an antipsychotic medication, taken by mouth) will be helpful in reducing symptoms (such as hearing voices, having trouble in organizing your thoughts, lack of interest in life events and social activities), compared to placebo (an inactive substance, "sugar pill"), when added to clozapine in patients with schizophrenia.

The participant will be asked to come in once a week to meet with the research staff and study doctor. The participant will continue to see your regular clinician during this study for all normal appointments. The participant will remain on your current medications throughout the study. During the study you will be randomly selected to be put on a small dose of Pimozide or placebo.

If you choose to participate, you will first have screening tests to find out if you are eligible. The study physician will do a number of tests including a physical examination, a routine medical history, lab tests for blood and urine, and EKG (to monitor your heart) and interviews about your physical and mental health.

At each visit you will complete an EKG (to monitor your heart), vital signs, and discuss how you are feeling with the research staff and doctor. Once a month, we will also conduct a slightly longer interview with you about your symptoms and draw one tube of blood to check your Clozapine level. At the beginning and end of the study, you will do some pencil and paper games called "Neurocognitive tests".

If you are interested in participating in this study, we will go over it in greater detail with you, including the possible benefits and risks associated with participating. We will make sure you understand the study before you begin. This study is completely voluntary, which means that you can choose to stop participating in the study at any time.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Pimozide
    half of the subjects are randomized to the active drug
  • Drug: placebo
    half of the subjects are randomized to placebo
  • Placebo Comparator: 1
    placebo pimozide
    Intervention: Drug: placebo
  • Active Comparator: 2
    active pimozide
    Intervention: Drug: Pimozide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder.
  • A minimum Brief Psychiatric Rating Scale (BPRS) score of 35 and a BPRS psychotic symptom cluster score of at least 8.
  • Currently taking clozapine with a blood level between 350-1000 ng/ml and on a stable dose of clozapine for the past 2 weeks.
  • Able to give informed consent.

Exclusion Criteria:

  • A history of significant medical/neurological disease such as thyroid, renal, hepatic abnormality, seizure disorder.
  • History of Neuroleptic Malignant Syndrome.
  • Current substance abuse determined by urine toxicology.
  • Cardiac arrhythmia, sinus bradycardia (heart rate less than 60/min), sinus tachycardia (heart rate greater than 110/min), supraventricular tachycardia, ventricular tachycardia, Wolff-Parkinson-White Syndrome, first, second, third degree atrioventricular (AV) block, atrial fibrillation, atrial flutter and junctional complexes. in baseline electrocardiogram (EKG). Study doctors will examine the EKGs and consult with an internist/cardiologist as needed.
  • on EKG: QTc > 450 ms.
  • Current use of macrolide antibiotics (e.g., erythromycin, clarithromycin), azole antifungal agents (e.g., ketoconazole, itraconazole), protease inhibitors (e.g., ritonavir, indinavir), nefazodone, and other medications that are associated with prolonged QTc.
  • Current use of antipsychotics other than clozapine.
  • Current use of sertraline.
  • IQ level below 70.
  • At high risk for suicidal/homicidal behavior.
  • Pregnancy, lack of birth control for females of childbearing age (female patients must report use of effective method for birth control such as birth control pills, condoms, barrier methods, abstinence or have written statement from their doctors that they are medically sterile).
  • Non-English speaking.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00374244
02T-251
No
Handan Gunduz-Bruce, Yale University
Yale University
Stanley Medical Research Institute
Principal Investigator: Handan Gunduz-Bruce, MD Yale University School of Medicine, Dept of Psychiatry
Yale University
January 2012

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