Ethyl-Eicosapentaenoic Acid and Tardive Dyskinesia
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ClinicalTrials.gov Identifier: NCT00114595 |
Recruitment Status
:
Completed
First Posted
: June 16, 2005
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dyskinesia Schizophrenia | Drug: eicosapentaenoic acid | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Enrollment : | 84 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Double-Blind, Randomised, Parallel-Group Comparison of Ethyl-Eicosapentaenoic Acid (Ethyl-EPA) Versus Placebo as Add-on Medication in Patients With Established Tardive Dyskinesia |
Study Start Date : | April 2003 |
Study Completion Date : | March 2005 |

- Change in Extrapyramidal Symptom Rating Scale (ESRS) dyskinesia score from baseline to week 12.
- Change in ESRS for parkinsonism, dystonia, akathisia, and total scores from baseline to week 12
- The proportion of subjects in each group who achieve a 30% reduction in ESRS total scores at week 12
- Time to remission (defined as a 30% reduction in ESRS total scores)
- The proportion of patients achieving a CGI Severity of TD score of < 3 at 12 weeks
- Change in Positive and Negative Syndrome Scale (PANSS) total, positive, negative and general psychopathology scores from baseline to week 12

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female aged 18 to 60 yrs
- Meeting Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV) criteria for TD.
- Meeting DSM-IV criteria for schizophrenia or schizo-affective disorder.
- CGI severity of TD score >3.
- Patients from whom informed, written consent is obtained.
- Patients who have been on a fixed dose of antipsychotic medication for at least 6 weeks prior to trial entry.
Exclusion Criteria:
- Significant neurological disorder other than TD
- Substance abuse
- Significant other medical illness
- Psychiatric disorder not stabilised
- Patients currently receiving clozapine
- Pregnancy or lactation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114595
South Africa | |
Department of Psychiatry, Department of Health sciences, University of Stellenbosch | |
Cape Town, Western Cape, South Africa, 7500 |
Principal Investigator: | Robin Emsley, MD |
ClinicalTrials.gov Identifier: | NCT00114595 History of Changes |
Other Study ID Numbers: |
2002/M044 02T-140 N2/190802 |
First Posted: | June 16, 2005 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | June 2005 |
Keywords provided by University of Stellenbosch:
eicosapentaenoic acid tardive dyskinesia omega-3 schizophrenia |
Additional relevant MeSH terms:
Dyskinesias Tardive Dyskinesia Dyskinesia, Drug-Induced Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders |
Movement Disorders Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms |