Conversion to Antipsychotic Monotherapy

NCT01368458 | Terminated

• 1 other identifier: 07I/C31
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a 12-week, with a 32-week follow-up, rater-blind, randomized controlled trial to determine whether patients with chronic schizophrenia or schizoaffective disorder receiving two different antipsychotics simultaneously will have any significant change in psychopathology following conversion to antipsychotic monotherapy. Additionally, the effects of conversion to antipsychotic monotherapy will be assessed by neurocognitive tests. The study will be conducted at the Clinical Research and Evaluation Facility (CREF), a specialized research unit jointly operated by the Nathan S Kline Institute for Psychiatric Research (NKI) and Rockland Psychiatric Center (RPC). Patients will be recruited from the regular in-patient units of RPC and transferred to the CREF. Following baseline assessments, patients will be randomized to continued antipsychotic polypharmacy treatment or to systematic conversion to monotherapy. Conversion to antipsychotic monotherapy will be assessed across multiple domains of psychopathology using the Positive and Negative Symptom Scale (PANSS). The primary outcome measure is PANSS total score. The secondary outcome measure is time on medication (all-cause dropouts). Mixed Model Repeated Measures (MMRM) will test the hypothesis that conversion to antipsychotic monotherapy will show minimal change from the control group.

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (2)

• Positive and Negative Symptom Scale (PANSS) total score

  12 weeks

• Relapse Rate

  12 weeks

Secondary Outcomes (8)

• Nurses Observation Scale for Inpatient Evaluation (NOSIE)

  12 weeks

• Abnormal Involuntary Movement Scale (AIMS)

  12 weeks

• Simpson-Angus Scale (SAS)

  12 weeks

• Barnes Akathisia Scale

  12 weeks

• MATRICS

  12 weeks

Study Arms (2)

Conversion to mono therapy

EXPERIMENTAL

Conversion from 2 to 1 antipsychotic

Other: Conversion to Antipsychotic Monotherapy

control

NO INTERVENTION

No change in antipsychotics

Interventions

Conversion to Antipsychotic Monotherapy OTHER

Patients assigned to the antipsychotic monotherapy group will have the dosage of their secondary (i.e. one due to be reduced) antipsychotic reduced by decreased by approximately 1/3 every 3 weeks. Dosage of the primary antipsychotic will be left unchanged.

Conversion to mono therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-64 with a SCID DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder, confirmed by SCID, who are able to give written informed consent and on stable dosages of two antipsychotics for at least one month prior to baseline.

You may not qualify if:

• Lack of capacity to give informed consent (capacity is determined by a licensed member of the treatment team)
• unstable medical illness
• use of long acting injectable preparations of antipsychotic medication in the previous two months
• documented failure of previous dose reduction
• current treatment with clozapine
• addition of any new psychotropic in the previous month
• patients who are severely assaultive and in clinical need of more than one antipsychotic for their safe management

Sponsors & Collaborators

• Nathan Kline Institute for Psychiatric Research: lead

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Joshua Kantrowitz, MD

  Nathan Kline Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2008
• First Posted: June 8, 2011
• Study Start: December 1, 2007
• Study Completion: July 1, 2008
• Last Updated: February 9, 2017

Record last verified: 2017-02