Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00161044 |
| Other study ID # |
H-23059 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2004 |
| Est. completion date |
September 2005 |
Study information
| Verified date |
March 2022 |
| Source |
University of Maryland, Baltimore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
