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Synopsis SEQUEL Study A non-interventional naturalistic project to

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									                       Synopsis SEQUEL Study
  A non-interventional naturalistic project to investigate the effect of the
 use of SMS text service on treatment adherence in patients treated with
                         Seroquel® (quetiapine)
                 NCT 00533260 NIS-NNL-SER-2007/1
Primary objective: To investigate the effect of daily treatment reminders, delivered via an
SMS text message service, on adherence to treatment by assessment of the Medication
Adherence Rating Scale (MARS) after 12 weeks treatment with quetiapine.

Secondary objectives:
  ! To investigate the effect of daily treatment reminders, delivered via an SMS text
     message service, on treatment adherence by assessment of the Medication
     Adherence Rating Scale (MARS) after 4 weeks treatment with quetiapine.
  ! To investigate the effect of daily treatment reminders, delivered via an SMS text
     message service, on treatment adherence by assessment of prescription receipt at the
     pharmacy after 4 and 12 weeks treatment with quetiapine.
  ! To investigate the effect of daily treatment reminders, delivered via an SMS text
     message service, on clinical outcome by assessment of Clinical Global Impression
     (CGI) after 4 and 12 weeks treatment with quetiapine.
  ! To investigate if a regular patient remote contact via a simple SMS text message is a
     practical acceptable proposition in this group of patients and is considered a useful
     and acceptable tool by the participating physicians.

First Patient First Visit: 03 July 2007.

Last Patient Last Visit: 10 April 2008.

Number of patients: In total 128 patients were included in the study, of which 121 patients
were included in the efficacy analysis.

Main criteria for inclusion: Patients who were diagnosed with schizophrenia or bipolar
disorder. Patients who recently suffered from a manic episode, and for whom it was decided
to start with quetiapine treatment.

Criteria for evaluation:

Efficacy:
Primary outcome
Change from baseline MARS in SMS cohort patient population compared with change from
baseline MARS in ‘without’ SMS patient cohort after 12 weeks.

Secondary outcomes
   1. Change from baseline MARS in SMS cohort patient population compared with
      change from baseline MARS in without SMS patient cohort after 12 weeks.
   2. Change from baseline MARS in SMS cohort patient population compared with
      change from baseline MARS in without SMS patient cohort after 4 weeks,
   3. Recipe retrieval, measured by asking the patient and the appropriate pharmacy,
      differences between the SMS cohort patient population compared with the without
      SMS patient cohort after 4 and 12 weeks,
   4. Change from baseline CGI in SMS cohort patient population compared with change
      from baseline CGI in without SMS patient cohort after 4 and 12 weeks,
   5. Evaluation of the answers on the questions concerning the feasibility and
      acceptability of the use of the SMS text message service.

Safety:
Adverse events that lead to discontinuation of study drug.
Serious adverse events reported during the study.

Results:
The mean change from baseline in MARS scores for the SMS cohort (1.6 at visit 3) was
significant, whereas for the without SMS patient cohort no clear change could be observed.
In accordance, the difference in mean change from baseline between the two cohorts was
significant at both visits (p<0.0002 for Visit 2 and p<0.0076 for Visit 3).
Regarding recipe retrieval no apparent and significant differences could be observed
regarding this between the SMS and the ‘without’ SMS cohort.
On the average the CGI scores decreased significantly during the study for both the SMS set
(-0.6) and the ‘without’ SMS set (-1.1) which indicates that the severity of illness decreased in
both groups. No significant differences could be observed between the cohorts regarding
these decreases in CGI.
About 95% of the physicians were satisfied with the SMS services during the complete study.
The percentage of satisfied patients was slightly lower at visit 2 (88.5%) and decreased
during the study to 75%.
Most patients continued the treatment during (96.1%) and after (94.3%) the study. Only in 4
cases the reason to stop treatment was an adverse event. In addition, two serious adverse
events were reported in 2 patients, which caused hospitalization but did not lead to treatment
discontinuation.

								
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