Polypharmacy in Clozapine-resistant Schizophrenia

NCT00918021 | Completed Phase 4

• 2 other identifiers: 2009-011307-220911885
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized, double-blind study is to verify the hypothesis that clozapine monotherapy is as efficient as a combination of clozapine and olanzapine therapy in treatment-resistant schizophrenia. A third of schizophrenia patients are non -responders to medications used nowadays. These patients are usually treated with clozapine, but a large proportion of patients don't recover sufficiently. Therefore, these patients are treated with combination of two or more drugs to achieve better treatment results. Until now the scientific evidence has been insufficient to assess the utility of polypharmacy. The aim is to study during 2009 with voluntary patients, if there is any benefit of olanzapine augmentation compared with pure clozapine monotherapy. During the study the patients are not exposed to any additional intervention. The intervention in this study is just to reduce the previously used polypharmacy. Methods: This study lasts for 24 weeks. Participants (30) are randomized in one of two alternative interventions (A or B) before the study. After 12 weeks the intervention arms cross over (from A to B and from B to A). Group B: In addition to clozapine, the participants receive their normal dosage of olanzapine (=the same as on the hospital ward) for 12 weeks, next the decreasing dosage of olanzapine for four weeks and subsequently placebo for 8 weeks Group A: : In addition to clozapine the participants receive the decreasing dosage of olanzapine for four weeks, next placebo for 8 weeks, after that the increasing dosage of olanzapine for four weeks and subsequently the normal dosage of olanzapine for 8 weeks The response for the medical treatment is assessed by Clinical Global Improvement Scale (CGIS) and Global Assessment of Functioning (GAF) -scale. The primary outcomes are GAF and modified CGIS during the parallel phase of the study (the first 12 weeks). The second phase (the last 12 weeks) of the cross-over study is used in the secondary analysis. The use of additional medication (such as benzodiazepines) is used as a secondary outcome measure.

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

• The primary outcomes are GAF and modified CGIS during the parallel phase of the study (the first 12 weeks).

  0, 12, 24 weeks

Secondary Outcomes (1)

• The second phase (the last 12 weeks) of the cross-over study is used in the secondary analysis. The use of additional medication (such as benzodiazepines) is used as a secondary outcome measure.

  0, 12, 24 weeks

Study Arms (2)

olanzapine (B)

ACTIVE COMPARATOR

Group B: In addition to clozapine, the participants receive their normal dosage of olanzapine (=the same as on the hospital ward) for 12 weeks, next the decreasing dosage of olanzapine for four weeks and subsequently placebo for 8 weeks.

Drug: olanzapine

placebo (A)

PLACEBO COMPARATOR

Group A: : In addition to clozapine the participants receive the decreasing dosage of olanzapine for four weeks, next placebo for 8 weeks, after that the increasing dosage of olanzapine for four weeks and subsequently the normal dosage of olanzapine for 8 weeks.

Drug: placebo

Interventions

olanzapine DRUG

normal dosage of olanzapine (the same dosage as on hospital ward)

Also known as: Solazin

olanzapine (B)

placebo DRUG

placebo

placebo (A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18 years, (adult), legally competent
• the patient is able to understand the purpose of the study and is eligible to sign the written informed consent form.
• insufficient response to the valid clozapine-olanzapine -polypharmacy
• psychotropic medication has been constant (unchangeable) during the past 2 months

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• Niuvanniemi Hospital: lead

Study Sites (1)

Niuvanniemi Hospital

Kuopio, FI-70240, Finland

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jari Tiihonen, MD, PhD

  Niuvanniemi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 11, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: November 19, 2010

Record last verified: 2010-11

Locations

FI (1)