Randomized Double Blind Placebo Control Study in Patients with Schizophrenia

NCT01602029 | Completed Phase 2 DMC

• 1 other identifier: roses_pill
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 3

Brief Summary

Negative symptoms and cognitive deficits are two partially-related features of schizophrenia which have a major negative impact on social function and objective quality of life. Standard drug treatments have little impact on either and arguably no effect on primary negative symptoms. Social dysfunction has major economic consequences in both the developed and developing world. There is evidence that anti-inflammatory treatment may have beneficial effects in patients with schizophrenia.

Conditions

Schizophrenia; Schizoaffective Disorder; Psychosis Not Otherwise Specified; Schizophreniform Disorder

Keywords

Anti inflammatory; Schizophrenia; Simvastatin; Ondansetron

Outcome Measures

Primary Outcomes (1)

• Negative symptom severity

  Negative symptom severity as defined by negative syndrome subscale score on the Positive and Negative Syndrome Scale

  6 months

Secondary Outcomes (1)

• cognitive functioning

  6 months

Study Arms (4)

Ondansetron

ACTIVE COMPARATOR

ondansetron added to TAU Ondansetron will be administered in 8mg once daily dose

Drug: Ondansetron

Simvastatin

ACTIVE COMPARATOR

Simvastatin added to TAU Simvastatin 20mg taken as once daily dose

Drug: Simvastatin

Placebo

PLACEBO COMPARATOR

Placebo added to TAU

Drug: Placebo

Odansetron Plus Simvastatin

ACTIVE COMPARATOR

Ondansetron will be administered in 8mg once daily dose and Simvastatin 20mg taken as once daily dose

Drug: Odansetron plus simvastatin

Interventions

Ondansetron DRUG

ondansetron added to TAU Ondansetron will be administered in 8mg once daily dose

Ondansetron

Simvastatin DRUG

Simvastatin added to TAU Simvastatin 20mg taken as once daily dose

Simvastatin

Placebo DRUG

Placebo added to TAU

Placebo

Odansetron plus simvastatin DRUG

Ondansetron will be administered in 8mg once daily dose and Simvastatin 20mg taken as once daily dose

Odansetron Plus Simvastatin

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 to 65 years
• Patients will be recruited both from inpatients and outpatients.
• Diagnostic and Statistical Manual-IV (DSM-IV TR) diagnosis of schizophrenia, schizoaffective disorder, psychosis not otherwise specified or schizophreniform disorder
• Competent and willing to give informed consent
• Stable on medication 4 weeks prior to baseline
• No planned medication change
• Able to take oral medication and likely to complete the required evaluations
• Female participants of child bearing age must be willing to use adequate contraceptives for the duration of the study, and, willing to have a pregnancy test pre treatment and at ten weekly intervals while on study medication,
• Not planning to relocate in the next 12 months

You may not qualify if:

• Relevant ICD 10 organic brain disease or neurological diagnoses (including ECG conduction abnormalities, neurological disorder, or an active seizure)
• Subjects who will meet the criteria for a DSM-IV TR diagnosis of alcohol or substance abuse (other than for nicotine) within the last month or the criteria for DSM-IV TR alcohol or substance dependence (other than for nicotine) within the last 6 months
• Any change of psychotropic medications within the previous 4 weeks
• Pregnant or lactating women and those of reproductive age without adequate contraception

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead
• Stanley Medical Research Institute: collaborator
• Dow University of Health Sciences: collaborator
• Abbasi Shaheed Hospital: collaborator

Study Sites (3)

Abbasi Shaheed Hospital

Karachi, Sindh, Pakistan

Location

Dow university of Health Sciences

Karachi, Sindh, Pakistan

Location

Karwan e hayat

Karachi, Pakistan

Location

Related Publications (1)

• Chaudhry IB, Husain N, Husain MO, Hallak J, Drake R, Kazmi A, Rahman Ru, Hamirani MM, Kiran T, Mehmood N, Stirling J, Dunn G, Deakin B. Ondansetron and simvastatin added to treatment as usual in patients with schizophrenia: study protocol for a randomized controlled trial. Trials. 2013 Apr 17;14:101. doi: 10.1186/1745-6215-14-101.

  PMID: 23782463 DERIVED

Related Links

• Website of Pakistan Institute of Learning \& Living

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Ondansetron; Simvastatin

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; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Imran Chaudhry, MD

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: May 18, 2012
• Study Start: August 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 10, 2024

Record last verified: 2012-05

Locations

PA (3)