Study Evaluating Safety and Tolerability of Ascending Multiple Dose of SLV-313 in Schizophrenia Patients

Wyeth

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: SLV-313 SR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00581243

3170A1-01001

Details and patient eligibility

About

Randomized, inpatient, ascending multiple dose study given to subjects with schizophrenia and schizoaffective disorder to assess safety and tolerability.

Enrollment: 32 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men, aged 18-50 years old
• Women, aged 18-50 years old

Exclusion criteria

• Non-lactating women, aged 18-50 years old
• Non-pregnant women, aged 18-50 years old

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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32 participants in 4 patient groups

1

Experimental group

Description:

2 mg SLV-313 SR (fixed dose)

Treatment:

Drug: SLV-313 SR

2

Experimental group

Description:

5 mg SLV-313 SR (fixed dose)

Treatment:

Drug: SLV-313 SR

3

Experimental group

Description:

10 mg SLV-313 SR (fixed dose)

Treatment:

Drug: SLV-313 SR

4

Experimental group

Description:

xx mg SLV-313 SR (titration)

Treatment:

Drug: SLV-313 SR