Effectiveness of Pimozide in Augmenting the Effects of Clozapine in the Treatment of Schizophrenia
Condition: Schizophrenia; Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Pimozide; Placebo
Intervention description: Each capsule of active treatment will contain 2 mg of pimozide. Dosing will be flexible and will range from a minimum of 2 mg per day to 8 mg per day. Dosing will begin at Week 1 with 1 capsule per day. This will be slowly titrated at a rate of 1 capsule per week to a maximum of 4 capsules depending upon clinical response and side effects.; Active drug and placebo will be encapsulated in an identical fashion. The placebo capsule will be made to match in appearance and weight. There will be flexible dosing, allowing a minimum of 1 capsule per day to 4 capsules per day, in order to match the dosing range of the active treatment.
Intervention MeSH terms: Pimozide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Clozapine; Treatment; Combination; Unresponsive; Schizoaffective Disorders

Summary:

      This study will assess the effectiveness of pimozide in enhancing the effects of clozapine in
      the treatment of schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of schizophrenia according to DSM-IV criteria

          -  Any schizoaffective disorder or subtype

          -  Score greater than 60 on the Positive and Negative Syndrome Scale (PANSS)

          -  Currently taking clozapine

          -  Score of four or higher on two or more items from the positive symptom subscale of the
             PANSS

          -  Score of 4 or greater on the Clinical Global Impression (CGI) scale

          -  Clozapine plasma level greater than 378 µg/ml

          -  Stable dose of clozapine demonstrated to have been associated with a clozapine plasma
             level greater than 378 µg/ml for at least eight weeks

          -  Able to read at an 8th grade level or above

        Exclusion Criteria:

          -  History of unstable coronary artery disease

          -  Congestive heart failure

          -  History of long Q-T syndrome

          -  History of cardiac arrhythmia

          -  History of cardiac conduction delay

          -  Baseline QT correction score greater than 0.425 seconds

          -  Liver disease

          -  History of stroke

          -  History of Neuroleptic Malignant Syndrome

          -  Hypokalemia

          -  Hypocalcemia

          -  Current blindness, deafness, language difficulties, or any other disability which may
             prevent participation or cooperation in the study

          -  Current suicidal or homicidal thoughts

          -  Currently abusing psychoactive substances

          -  Currently receiving antidepressants, thymoleptics, L-DOPA, buspirone, or
             antipsychotics other than clozapine (Valproic acid and Divalproex sodium are not
             criteria for exclusion)