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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01121042




Registration number
NCT01121042
Ethics application status
Date submitted
9/05/2010
Date registered
12/05/2010
Date last updated
14/10/2020

Titles & IDs
Public title
Double Blind, Placebo-Controlled, Randomised Investigation of Ondansetron in Schizophrenia
Scientific title
Double Blind, Placebo-Controlled, Randomised Investigation of Ondansetron in Schizophrenia
Secondary ID [1] 0 0
145/10
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizoaffective and Schizophreniform Disorders 0 0
Schizophrenia 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Schizophrenia
Mental Health 0 0 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ondansetron
Treatment: Drugs - Placebo

Active Comparator: Ondansetron - Ondansetron oral capsule 8mg daily

Placebo Comparator: Placebo - Placebo (100% lactose) matched oral capsule


Treatment: Drugs: Ondansetron
8mg per day oral capsule

Treatment: Drugs: Placebo
daily oral capsule matched to active study medication. Made form 100% lactose powder
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Positive and Negative Symptom Scale (PANSS)
Timepoint [1] 0 0
At screening visit and at three monitoring visits (week 4, week 8, week 12)
Secondary outcome [1] 0 0
The Montgomery Åsberg Depression Rating Scale (MADRS)
Timepoint [1] 0 0
At baseline visit and at three monitoring visits (week 4, week 8, week 12)
Secondary outcome [2] 0 0
Blood Test= C-Reactive Protein (CRP)
Timepoint [2] 0 0
Screening visit and monitoring visit (week 12)

Eligibility
Key inclusion criteria
1. Aged between 18-65 years of age

2. Have a current DSM-IV-TR diagnosis of schizophrenia, schizoaffective of
schizophreniform disorders (diagnosis will be confirmed using the MINI
Neuropsychiatric Interview)

3. 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

4. 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.

5. Have a level of understanding sufficient to provide informed consent and to
communicate with the investigators, study coordinator, and site personnel.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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.

2. Currently pregnant or breastfeeding

3. Have a current DSM-IV-TR diagnosis of substance abuse or dependence disorder, or
another Axis I disorder

4. Regularly use of another 5HT3 antagonist such as metoclopramide, cocaine, tropisetron,
granisetron, palonosetron

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2018
Sample size
Target
Accrual to date
Final
85
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Alfred Psychiatry Research Centre (MAPrc) - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01121042
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Professor Jayashri Kulkarni
Address 0 0
Monash Alfred Psychiatry Research Centre (MAPrc)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01121042