Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Residual Schizophrenia

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Avanir Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Schizophrenia

Treatments

Drug: Placebo
Drug: AVP-786

Study type

Interventional

Funder types

Industry

Identifiers

NCT02477670
15-AVP-786-202

Details and patient eligibility

About

The objectives of this 12-week study are to evaluate the efficacy, safety, and tolerability of AVP-786 as an adjunctive treatment compared with placebo in patients with residual schizophrenia.

Enrollment

145 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients who meet DSM-IV-TR diagnostic criteria for schizophrenia using the M.I.N.I. version 6.0.
  • Patients must meet PANSS criteria
  • Patients currently receiving atypical antipsychotics are eligible provided they are on a stable dose

Exclusion criteria

  • Patients with current major depressive disorder (MDD)
  • Patients with extrapyramidal syndrome secondary to their ongoing antipsychotic medication
  • Patients currently using anticholinergic medications
  • Recent in-patient hospitalization

Trial design

145 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Placebo capsules administered twice a day over a 12-week period
Treatment:
Drug: Placebo
AVP-786
Experimental group
Description:
AVP-786 dose 2 capsules administered twice a day over a 12-week period
Treatment:
Drug: AVP-786

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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