An Open-Label Investigation of the Adjuvant Therapeutic Effects of Galantamine in Patients With Chronic Schizophrenia and Persistent Deficit Symptoms
Condition: Chronic Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The purpose of this study is to see if galantamine is an effective agent for the treatment of
      the cognitive abnormalities, negative symptoms, and /or behavioral impairments seen in
      schizophrenia.
    

Detailed description: 
      In this exploratory investigation, we propose to study the adjuvant therapeutic efficacy and
      safety of galantamine in 20 patients with chronic schizophrenia, who are maintained on a
      stable regimen of antipsychotic medication for at least two weeks prior to enrollment (see
      Table 1 for Selection Criteria). Assessments of neuropsychological performance will be made
      prior to the start of galantamine therapy and at study endpoint. Upon enrollment,
      neuropsychological tests will be administered by the study neuropsychologist, or a trained
      and supervised assessment technician; in fixed order, and according to standardized testing
      procedures. The following tests will be administered: (1) Repeatable Battery for the
      Assessment of Neuropsychological Status (RBANS) (covering (a) verbal and visual episodic
      memory, (b) verbal response generation and self-monitoring, (c) auditory attention and
      working memory, and (d) sustained attention and psychomotor speed); and (2) Grooved Pegboard
      Test (motor speed). RBANS administration will be counterbalanced (using Forms A and B) across
      subjects and assessment points to prevent order effects. Remaining assessments will be
      administered at baseline, after galantamine titration, and at weeks 4 and 8 of galantamine
      treatment. Psychiatric symptoms and behavior will be assessed using the Brief Psychiatric
      Rating Scale (BPRS), the Scale for the Assessment of Negative Symptoms (SANS), the
      Montgomery-Asberg Depression Rating Scale (MADRS); the Neuropsychiatric Inventory (NPI); the
      Clinical Global Impression Scale (CGI); and the Apathy Evaluation Scale (AES). Trained
      research nurses, psychologists and psychiatrists, will administer the symptom, behavior and
      functional scales with established inter-rater reliability. In this study, adverse effects
      will be monitored through self-reporting and observation. Vital signs will be collected on a
      weekly basis. Additionally, motor and movement side effects will be rated by trained research
      nurses, using the Extrapyramidal Symptom Rating Scale (EPRS), the Barnes Akathisia Scale
      (BAS); and the Abnormal Involuntary Movements Scale (AIMS). Following their initial
      neuropsychological assessment patients will enter a ¿three week galantamine titration phase¿
      during which galantamine will be added to the stable regimen of antipsychotic medication
      according to the following titration schedule: 8 mg/day for the first week, followed by 16
      mg/day in the second and 24 mg/day in the third week (Raskin et al., 2000). At the end of
      this titration phase, patients will be receiving the maximal allowable dose of galantamine
      (i.e., 24 mg/day) or an optimal dose (i.e., the highest tolerable dose devoid of significant
      side effects [e.g., 16 mg/day]). Moreover, at the end of this titration phase, patients will
      be administered the standard battery of rating instruments prior to entering an 8-week period
      of active treatment with the maximal or optimal adjuvant therapeutic dose of galantamine.
      During the active treatment phase, the standard battery of rating instruments will be
      administered at the end of the fourth and eighth week of active treatment. Patients admitted
      to the 364A Unit at Perry Point will have their charts reviewed to see if they meet the
      inclusion criteria for the study. After approval by the principal investigator the patient
      will be approached by a designated member of the research team for their interest in
      participating in the study.
    

Intervention name(s): Galantamine
Intervention type(s): Drug
Intervention MeSH terms: Galantamine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment