## Protocol Section
### Identification Module
**NCT ID:** NCT00141479

**Brief Title:** To Evaluate the Impact of Treatment Interruption on Re-initiation of Bifeprunox

**Official Title:** A Single-center Safety and Tolerability Study to Evaluate the Impact of Treatment Interruption on Re-initiation of Bifeprunox in Subjects With Schizophrenia or Schizoaffective Disorder

#### Organization Study ID Info
**ID:** S154.2.013
#### Organization
**Class:** INDUSTRY
**Full Name:** Solvay Pharmaceuticals
### Status Module
#### Completion Date
**Date:** 2006-11

**Type:** ACTUAL

#### Last Update Post Date
**Date:** 2015-01-16

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-01-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2006-11

**Type:** ACTUAL

#### Start Date
**Date:** 2005-05

**Status Verified Date:** 2006-05

#### Study First Post Date
**Date:** 2005-09-01
**Type:** ESTIMATED
**Study First Submit Date:** 2005-08-30
**Study First Submit QC Date:** 2005-08-30
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** H. Lundbeck A/S

**Class:** INDUSTRY

**Name:** Wyeth is now a wholly owned subsidiary of Pfizer

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Solvay Pharmaceuticals

### Description Module

**Brief Summary:** The purpose of this study is to investigate a safe treatment interruption interval(s) for re-initiation of bifeprunox at a therapeutic dose. The study duration is approximately 7 to 10 weeks.

### Conditions Module

**Conditions:**

- Schizophrenia

- Schizoaffective Disorder

**Keywords:**

- Treatment interruption on reinitiation

- Schizophrenia

- Schizoaffective disorder

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** DOUBLE

**Primary Purpose:** TREATMENT

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Bifeprunox

**Type:** DRUG

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Diagnosis of Schizophrenia or Schizoaffective disorder
* 18-55 years

Exclusion Criteria:

* Subjects who are acutely psychotic
* Subjects with current Axis I primary psychiatric diagnosis other than schizophrenia
* Subjects at significant risk of suicide
* Subjects with a seizure disorder

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Wichita

**Country:** United States

**Facility:** Site 1

**State:** Kansas

#### Overall Officials

**Official 1:**

**Affiliation:** Solvay Pharmaceuticals

**Name:** Global Clinical Director Solvay

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019967

- Term: Schizophrenia Spectrum and Other Psychotic Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M15376

- Name: Schizophrenia

- Relevance: HIGH

- As Found: Schizophrenia

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: HIGH

- As Found: Schizoaffective Disorder

- ID: M21838

- Name: Schizophrenia Spectrum and Other Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012559

- Term: Schizophrenia

- ID: D000011618

- Term: Psychotic Disorders

### Misc Info Module

- Version Holder: 2024-05-24
