Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001150831
Ethics application status
Approved
Date submitted
30/10/2012
Date registered
31/10/2012
Date last updated
1/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment of borderline personality disorder with omega-3 fatty acids in combination with valproic acid.
Scientific title
Treatment of impulsivity with omega-3 fatty acids in combination with valproic acid in a group of borderline personality disoder patients.
Secondary ID [1] 281466 0
Nil
Universal Trial Number (UTN)
U1111-1129-0346
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline personality disorder 287723 0
Condition category
Condition code
Mental Health 288060 288060 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eicosapentaenoic acid (EPA; 1.2 g/day) and docosahexaenoic acid (DHA; 0.8 g/day) in combination with valproic acid (800-1300 mg/day) (plasma range: 50-100 microg/ml). All drugs are administered daily for 12 weeks as oral tablets. The dose of valproic acid will be determined by treating clinician on the basis of plasma range.
Intervention code [1] 285967 0
Treatment: Drugs
Comparator / control treatment
Valproic acid (800-1300 mg/day) (plasma range: 50-100 microg/ml). The dose of valproic acid will be determined by treating clinician on the basis of plasma range.
Control group
Active

Outcomes
Primary outcome [1] 288265 0
Global symptomatology assesed with the Clinical Global Impression Scale, item Severity (CGI-S)
Timepoint [1] 288265 0
At baseline (T0) and after 4 (T1/2) and 12 (T1) weeks
Primary outcome [2] 288266 0
Borderline personality disorder psychopatology measured by Borderline Personality Disorder Severity Index (BPDSI)
Timepoint [2] 288266 0
At baseline (T0) and after 4 (T1/2) and 12 (T1) weeks
Primary outcome [3] 288267 0
Impulsivity measured with Barratt Impulsiveness Scale, version 11 (BIS-11)
Timepoint [3] 288267 0
At baseline (T0) and after 4 (T1/2) and 12 (T1) weeks
Secondary outcome [1] 299730 0
Aggression and hostility measured with Modified Overt Aggression Scale (MOAS)
Timepoint [1] 299730 0
At baseline (T0) and after 4 (T1/2) and 12 (T1) weeks
Secondary outcome [2] 299731 0
Affective symptoms evaluated with the Hamilton Rating Scales for Depression and Anxiety (HAM-D, HAM-A),
Timepoint [2] 299731 0
At baseline (T0) and after 4 (T1/2) and 12 (T1) weeks
Secondary outcome [3] 299732 0
Self harm beaviour assessed with Self Harm Inventory (SHI)
Timepoint [3] 299732 0
At baseline (T0) and after 4 (T1/2) and 12 (T1) weeks
Secondary outcome [4] 299745 0
Patient functioning measured with Social Occupational Functioning Assessment Scale (SOFAS)
Timepoint [4] 299745 0
At baseline (T0) and after 4 (T1/2) and 12 (T1) weeks

Eligibility
Key inclusion criteria
Patients with a diagnosis of borderline personality disorder
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Dementia, delirium and other cognitive disorders; schizophrenia and other psychotic disorders. Lifetime bipolar disorders. Concurrent major depressive episode. Substance abuse in the last two months.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 4659 0
Italy
State/province [1] 4659 0

Funding & Sponsors
Funding source category [1] 286240 0
University
Name [1] 286240 0
Centre for Personality Disorders, Psychiatric Clinic 1, Department of Neuroscience, University of Turin, Italy
Country [1] 286240 0
Italy
Primary sponsor type
University
Name
Centre for Personality Disorders, Psychiatric Clinic 1, Department of Neuroscience, University of Turin, Italy
Address
Centre for Personality Disorders, Psychiatric Clinic 1, Department of Neuroscience, University of Turin, via Cherasco 11, 10126, Turin, Italy
Country
Italy
Secondary sponsor category [1] 285039 0
None
Name [1] 285039 0
Address [1] 285039 0
Country [1] 285039 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288297 0
Comitato Etico interaziendale A.O.U. SAN GIOVANNI BATTISTA DI TORINO, A.O. C.T.O./ MARIA ADELAIDE DI TORINO
Ethics committee address [1] 288297 0
Corso Bramante 88/90 10126, Turin, Italy
Ethics committee country [1] 288297 0
Italy
Date submitted for ethics approval [1] 288297 0
19/09/2012
Approval date [1] 288297 0
23/10/2012
Ethics approval number [1] 288297 0
0045016

Summary
Brief summary
On the basis of research background, we will perform a RCT in order to assess efficacy and tolerability of omega-3 fatty acids in combination with valproic acid in a group of BPD patients. We will recruit consecutive outpatients with a DSM-IV-TR diagnosis of borderline personality disorder (BPD), who will be randomly assigned to two treatment arms for twelve weeks: (1) valproic acid (800-1300 mg/day) (plasma range: 50-100 microg/ml), (2) EPA (1.2 g/day) and DHA (0.8 g/day) in combination with the same dose of valproic acid. Patients will be assessed with the Clinical Global Impression Scale, item Severity (CGI-S), the Hamilton Rating Scales For Depression and Anxiety (HAM-D, HAM-A), the Social Occupational Functioning Assessment Scale (SOFAS), the BPD Severity Index (BPDSI), the Barratt Impulsiveness Scale, version 11 (BIS-11), the Modified Overt Aggression Scale (MOAS), and the Self Harm Inventory (SHI). Adverse effects will be evaluated with the Dosage Record and Treatment Emergent Symptom Scale (DOTES).
Trial website
Trial related presentations / publications
Bellino S, Bozzatello P, Brignolo E, Brunetti C, Bogetto F. Omega-3 fatty acids supplementation in psychiatric disorders: a systematic review,.
Curr Psychopharmacol, 2012, 1, 353-364.
Public notes

Contacts
Principal investigator
Name 34889 0
Address 34889 0
Country 34889 0
Phone 34889 0
Fax 34889 0
Email 34889 0
Contact person for public queries
Name 18136 0
Silvio Bellino
Address 18136 0
Centre for Personality Disorders, Psychiatric Clinic 1, Department of Neuroscience, University of Turin, via Cherasco 11, 10126, Turin, Italy
Country 18136 0
Italy
Phone 18136 0
0039-011-6634848
Fax 18136 0
0039-011-673473
Email 18136 0
[email protected]
Contact person for scientific queries
Name 9064 0
Silvio Bellino
Address 9064 0
Centre for Personality Disorders, Psychiatric Clinic 1, Department of Neuroscience, University of Turin, via Cherasco 11, 10126, Turin, Italy
Country 9064 0
Italy
Phone 9064 0
0039-011-6634848
Fax 9064 0
0039-011-673473
Email 9064 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCombination of Omega-3 Fatty Acids and Valproic Acid in Treatment of Borderline Personality Disorder: A Follow-Up Study.2018https://dx.doi.org/10.1007/s40261-017-0617-x
N.B. These documents automatically identified may not have been verified by the study sponsor.