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Trial registered on ANZCTR


Registration number
ACTRN12615000705583
Ethics application status
Approved
Date submitted
28/05/2015
Date registered
8/07/2015
Date last updated
19/02/2019
Date data sharing statement initially provided
19/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of quetiapine as an adjunct treatment to psychotherapy for Borderline Personality Disorder
Scientific title
Investigation of the benefits of using quetiapine as an adjunct treatment in addition to psychotherapy in patients diagnosed with severe Borderline Personality Disorder.
Secondary ID [1] 286755 0
Nil known
Universal Trial Number (UTN)
U1111-1170-3012
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder 295121 0
Condition category
Condition code
Mental Health 295365 295365 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The utility of quetiapine (25 - 200mg/day, oral) will be assessed in patients diagnosed with severe borderline personality disorder. Patients who have given informed consent will be randomly assigned to receive placebo or quetiapine in a double-blind study. Dose will be adjusted weekly in 25 mg/day increments depending on efficacy and tolerability. After 12 weeks, participants will commence evidence-based weekly individual in combination with group psychotherapy (assignment to Dialectical Behavior Therapy or Mentalisation Based Therapy by clinician discretion) while continuing on quetiapine or placebo treatment. Weekly psychotherapy will comprise a 1 h individual session and a 1-2 h group session administered by a mental health clinician. Safety and efficacy will be assessed at frequent intervals with the blinded study ending after 12 months of psychotherapy (15 months after commencing drug or placebo treatment).
Quetiapine or placebo medication will be dispensed weekly for up to 15 months (the end point of the study). Participants will bring the package from the medication that was dispensed the previous week to their weekly appointment to monitor adherence. The provision of psychotherapy is expected to assist in participant retention. Medical examination, questionnaires and blood tests will be used to monitor safety.
Intervention code [1] 291909 0
Treatment: Drugs
Intervention code [2] 292246 0
Treatment: Other
Comparator / control treatment
The control treatment will be placebo prior to (3 months) and then in tandem with psychotherapy (12 months). Placebo will comprise microcellulose tablets.
Control group
Placebo

Outcomes
Primary outcome [1] 295107 0
Borderline Symptom Severity is a composite primary outcome that will be assessed using the: Zanarini rating scale for borderline personality disorder (ZAN-BPD); Borderline Evaluation of Severity over Time (BEST); and Diagnostic Interview for Borderlines - Revised (DIB-R).
Timepoint [1] 295107 0
Monthly (first 3 months), 2-monthly (3-9 months), 3 monthly (9-15 months)
Secondary outcome [1] 314786 0
Anxiety severity will be measured using: Speilberger State and Trait Anxiety Inventory (STAI) and Hamilton Rating Scale for Anxiety (HAM-A)
Timepoint [1] 314786 0
Monthly (first 3 months); 2 monthly (3-9 months); 3 monthly (9-15 months)
Secondary outcome [2] 314785 0
Depressive symptoms using: Hamilton Rating Scale for Depression (HAM-D); Beck Depression Inventory (BDI); Quick Inventory of Depressive Symptomology (QID)
Timepoint [2] 314785 0
Monthly (first 3 months); 2 monthly (3-9 months); 3 monthly (9-15 months)

Eligibility
Key inclusion criteria
Age 18-65;
Primary diagnosis of borderline personality disorder;
Negative pregnancy test if of child-bearing age;
Not currently dependent on alcohol or illicit drugs;
Normal pre-study laboratory values.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lifetime diagnosis of schizophrenia or schizoaffective disorder according to DSM-5;
Lifetime diagnosis of bipolar disorder according to DSM-5;
Current severe major depressive episode according to DSM-5;
Current severe somatic illness;
Current substance abuse disorder (quetiapine has abuse potential);
Current psychotic disorder due to either substance use disorder or a general medical condition;
Use of drugs that induce or inhibit the metabolising cytochrome 3A4 enzymes within two weeks prior to week zero and during the course of the study;
Previous prescription of quetiapine;
Contraindication for antipsychotics;
Pregnant or lactating; if of child-bearing age, not taking appropriate contraceptive precautions.

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
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/03/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5106 0
Turning Point Drug and Alcohol Centre - Fitzroy
Recruitment hospital [2] 3807 0
Maroondah Hospital - Ringwood East
Recruitment postcode(s) [1] 12574 0
3065 - Fitzroy
Recruitment postcode(s) [2] 9693 0
3135 - Ringwood East

Funding & Sponsors
Funding source category [1] 291299 0
Charities/Societies/Foundations
Name [1] 291299 0
Eastern Health Foundation
Country [1] 291299 0
Australia
Primary sponsor type
Hospital
Name
Eastern Health
Address
Eastern Health, Level 4
5 Arnold St, Box Hill
Victoria 3128
Australia
Country
Australia
Secondary sponsor category [1] 289977 0
None
Name [1] 289977 0
Address [1] 289977 0
Country [1] 289977 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292866 0
Eastern Health Human Research and Ethics Committee
Ethics committee address [1] 292866 0
Ethics committee country [1] 292866 0
Australia
Date submitted for ethics approval [1] 292866 0
28/05/2015
Approval date [1] 292866 0
13/01/2016
Ethics approval number [1] 292866 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57414 0
Dr Jillian Broadbear
Address 57414 0
Spectrum, Eastern Health, 54 Gertrude Street, Fitzroy, Victoria, 3065
Country 57414 0
Australia
Phone 57414 0
+61,3,88333050
Fax 57414 0
Email 57414 0
jillian.broadbear@easternhealth.org.au
Contact person for public queries
Name 57415 0
Sathya Rao
Address 57415 0
Spectrum, Eastern Health,
4 Bona Street,
Ringwood East, Victoria, 3135
Country 57415 0
Australia
Phone 57415 0
+61,3,88333050
Fax 57415 0
Email 57415 0
sathya.rao@easternhealth.org.au
Contact person for scientific queries
Name 57416 0
Jillian Broadbear
Address 57416 0
Spectrum,
54 Gertrude Street,
Fitzroy, Victoria, 3065
Country 57416 0
Australia
Phone 57416 0
+61,3,88333050
Fax 57416 0
Email 57416 0
jillian.broadbear@easternhealth.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The clinical trial was terminated due to difficulties with participant recruitment. No participants completed this study.


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
No additional documents have been identified.