Serotonin 1A Agonists and Cognition in Schizophrenia

Northwestern University

Status and phase: Completed; Phase 3

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Drug: placebo; Drug: adjunctive treatment with buspirone

Study type: Interventional

Funder types: Other

Identifiers

NCT00178971

020724

Details and patient eligibility

About

Examines cognitive functioning in patients with schizophrenia or schizoaffective disorder who have been treated with antipsychotic medications. Patients will be assigned to take active medication (Buspar)or placebo along with their prescribed antipsychotic medication for six weeks. Patients' memory and problem-solving ability will be tested before and after medication.

Full description

Examines cognitive functioning in patients with schizophrenia or schizoaffective disorder who have been treated with olanzapine or risperidone for at least three months randomized to receive adjunctive treatment with a 5-HT1A agonist (buspirone, 15-30 mg/day)or placebo.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects must meet all of the following criteria to be eligible for participation in the current research study.

1. Subjects will be males and females between 18-65 years of age;
2. Subjects will have a definite diagnosis by DSM-IV criteria for Schizophrenia or Schizoaffective Disorder;
3. The subjects or their legal guardian must sign the informed consent;
4. Subjects currently being treated with olanzapine or risperidone for a duration of at least 3 months

Exclusion criteria

1. Subjects who are pregnant or lactating
2. Subjects who have brain damage and/or neurological disorders
3. Subjects who have current substance dependence
4. Subjects unable to provide informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

buspirone 15-30 mg qd

Treatment:

Drug: adjunctive treatment with buspirone

2

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo