Maintenance Treatment vs. Stepwise Drug Discontinuation in First-Episode Schizophrenia

Heinrich-Heine University, Duesseldorf

Status and phase: Completed; Phase 4

Conditions: Schizophrenia; Psychoses

Treatments: Other: maintained antipsychotic treatment vs. stepwise drug discontinuation

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT00159120

01GI 9932 - P 2.2.2.1 / 2

Details and patient eligibility

About

After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions prodrome based early intervention take place.

Full description

After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions pharmacologic early intervention strategies in case of early sign of relapse will be applied.

Enrollment: 71 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients after 1 year of maintenance treatment after their first-episode in schizophrenia (according ICD-10 F20)
• Age between 18 and 55
• Informed consent
• One year neuroleptic maintenance treatment
• Reaching stable course

Exclusion criteria

• Residence outside of the catchment area
• Legal reasons
• Insufficient knowledge of the german language
• Substance abuse or addiction
• Pregnancy
• Serious physical illness
• Organic brain disease
• Contraindication to neuroleptic treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

1

Active Comparator group

Description:

further maintenance antipsychotic treatment and prodrome-based early intervention

Treatment:

Other: maintained antipsychotic treatment vs. stepwise drug discontinuation

2

Experimental group

Description:

stepwise drug discontinuation (after 1 year maintenance antipsychotic treatment) and prodrome-based early intervention

Treatment:

Other: maintained antipsychotic treatment vs. stepwise drug discontinuation