| Trial name or title |
Trial 8047
F1D‐MC‐HGLB |
| Methods |
Allocation: random, no further details.
Blindness: double, no further details.
Duration: 28 weeks.
Design: parallel.
Location: not reported. |
| Participants |
Diagnosis: schizophrenia.
Age 18‐65 years.
Gender: not reported.
History: duration of illness not reported.
Setting: in‐ and outpatient. |
| Interventions |
1. Aripiprazole.
2. Olanzapine. |
| Outcomes |
Long‐time effectiveness and tolerability.
Global state: CGI, PG‐I.
General Mental State: PANSS.
Depression: MADRS.
Quality of life: SWN‐S, SF‐36.
Cognitive functioning: MOS.
Sexual functioning: GISF.
Health resource utilisation and resource utilisation costs, hospitalisation time.
Treatment‐emergent adverse events: EPS (SAS, BAS, AIMS).
Laboratory values.
Vital signs. |
| Starting date |
October 2003. |
| Contact information |
Eli Lilly and Company. |
| Notes |
|
