Phase 2
Completed N=356
A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia
Source: ClinicalTrials.gov NCT00044044 ↗Enrolled (actual)
356
Serious AEs
7.9%
Results posted
Apr 2011
Primary outcomePrimary: Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score — -5.0; -5.2; -8.0; -9.8 units on a scale — p=<0.05
Summary
The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score |
-5.0; -5.2; -8.0; -9.8; -7.9 | <0.05 sig |
| SECONDARY Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores |
-7.1; -7.2; -13.6; -16.0; -12.3 | <0.05 sig |
| SECONDARY Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores |
-0.5; -0.4; -0.8; -0.8; -0.7 | <0.05 sig |
| SECONDARY Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores |
-1.3; -1.1; -2.5; -2.7; -1.9 | <0.05 sig |
Eligibility Criteria
Inclusion criteria
- The patient has a primary diagnosis of schizophrenia
- The patient has been hospitalized with acute or relapsing schizophrenia within 3 weeks of screening
- The patient has had a duration of illness of at least one year.
- The patient has a BPRS score of at least 42 at baseline and a score of at least 4 in two or more items of the positive symptom subcluster on the PANSS
- The patient is able to remain off antipsychotic medication for a 4 day washout period
Exclusion criteria
- The patient has had psychiatric hospitalizations other than current hospitalizations within 1 month prior to screening.
- The patient is considered treatment resistant-Substance abuse-Prolactin level of > 200 ng/mL at baseline
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT00044044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.