Double Blind, Placebo-Controlled, Randomised Investigation of Ondansetron in Schizophrenia

NCT01121042 | Completed Phase 3 DMC

• 1 other identifier: 145/10
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the overall effectiveness of Ondansetron as an adjunctive or "add-on" medication in the treatment of Schizophrenia. This study is a double blind, placebo-controlled, randomised, 12 week trial.

Conditions

Schizoaffective and Schizophreniform Disorders; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Positive and Negative Symptom Scale (PANSS)

  The PANSS is a widely used, drug-sensitive, valid and reliable measure of psychopathology in schizophrenia. The PANSS is a formal interview, from which 30 symptoms are rated along a 7 point scale that ranges from 1 (absent) to 7 (extreme psychopathology). Schizophrenia symptom severity will be assessed with the PANSS and monitored to determine change in total, positive, negative, cognitive or general psychopathology symptoms.

  At screening visit and at three monitoring visits (week 4, week 8, week 12)

Secondary Outcomes (2)

• The Montgomery Åsberg Depression Rating Scale (MADRS)

  At baseline visit and at three monitoring visits (week 4, week 8, week 12)

• Blood Test= C-Reactive Protein (CRP)

  Screening visit and monitoring visit (week 12)

Study Arms (2)

Ondansetron

ACTIVE COMPARATOR

Ondansetron oral capsule 8mg daily

Drug: Ondansetron

Placebo

PLACEBO COMPARATOR

Placebo (100% lactose) matched oral capsule

Drug: Placebo

Interventions

Ondansetron DRUG

8mg per day oral capsule

Ondansetron

Placebo DRUG

daily oral capsule matched to active study medication. Made form 100% lactose powder

Placebo

Eligibility Criteria

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

You may qualify if:

• Aged between 18-65 years of age
• Have a current DSM-IV-TR diagnosis of schizophrenia, schizoaffective of schizophreniform disorders (diagnosis will be confirmed using the MINI Neuropsychiatric Interview)
• Have been treated with a stable and standard dose (as determined by the PORT Treatment Recommendations for schizophrenia \[33\]) of an atypical antipsychotic agent (not including amisulpride owing to its 5HT3 actions) as their primary antipsychotic treatment for a minimum of eight weeks before entry into the trial
• Are experiencing positive symptoms as evidenced by a score of \>15 on the Positive Syndrome Subscale of the PANSS, and/or negative psychotic symptoms as evidenced by a score of \>15 on the Negative Syndrome Subscale of the PANSS and /or significant cognitive dysfunction, as evidenced by at least 15 on the cognitive subscale. The cognition subscale used in this study, which included items of G10, G11, G12, P2, N5, and N7 from the PANSS were generated from previous studies.
• Have a level of understanding sufficient to provide informed consent and to communicate with the investigators, study coordinator, and site personnel.

You may not qualify if:

• Have an unstable medical condition, neurological disorder or an unstable seizure disorder. Any clinical significant electrocardiogram (ECG) abnormality at screening, including sinus bradycardia (ersting heart rate \<50 beats per minute), atrial fibrillation, 2nd or 3rd degree AV block (AVB), prolonged ATc (QTcF\>450ms in males or \>470ms in females) history of congenital long AT syndromes, or risk of Torsades de Pointes because of family history of sudden death.
• Currently pregnant or breastfeeding
• Have a current DSM-IV-TR diagnosis of substance abuse or dependence disorder, or another Axis I disorder
• Regularly use of another 5HT3 antagonist such as metoclopramide, cocaine, tropisetron, granisetron, palonosetron

Sponsors & Collaborators

• Bayside Health: lead

Study Sites (1)

Monash Alfred Psychiatry Research Centre (MAPrc)

Melbourne, Victoria, 3004, Australia

Location

Related Publications (1)

• Kulkarni J, Thomas N, Hudaib AR, Gavrilidis E, Gurvich C. Ondansetron - a promising adjunctive treatment for persistent schizophrenia. J Psychopharmacol. 2018 Nov;32(11):1204-1211. doi: 10.1177/0269881118798608. Epub 2018 Oct 25.

  PMID: 30359166 DERIVED

Related Links

• Monash Alfred Psychiatry Research Centre (MAPrc) website

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Professor Jayashri Kulkarni

  Monash Alfred Psychiatry Research Centre (MAPrc)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2010
• First Posted: May 12, 2010
• Study Start: July 1, 2010
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)