Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000131459
Ethics application status
Approved
Date submitted
31/03/2015
Date registered
4/02/2016
Date last updated
4/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Selectively modulating emotional memories: Can Propranolol block reconsolidation of non-fearful, non-craving emotional memories?
Scientific title
Does propranolol--compared to a placebo--affect memory performance in an emotional memory task conducted in healthy adults?
Secondary ID [1] 286454 0
Nil known.
Universal Trial Number (UTN)
U1111-1168-8873
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Memory reconsolidation blockade with Propranolol 294630 0
Memory consolidation blockade with Propranolol 294631 0
Emotional memory 294632 0
Condition category
Condition code
Mental Health 294930 294930 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be a 3-week, randomized, double-blind trial involving a total of 36 healthy participants. Consented participants meeting enrolment criteria will be randomized with a 33% chance to one of three groups:
(1) In Group A, we will give oral propranolol (tablet) at time 1 (T1) and a placebo (oral tablet) at time 2 (T2);
(2) In Group B, we will give a placebo (oral tablet) at T1 and oral propranolol (tablet) at T2;
(3) In Group C (control group), we will give a placebo (oral tablet) on the first two testing days.

All participants will undergo a testing session once a week for a three-week period. Participants will consolidate and reconsolidate affective images drawn from the International Affective Pictorial System (IAPS) at Sessions 1 (Time 1; T1, 2 hours duration) and 2 (Time 2; T2, 1.5 hours duration), respectively, by rating each image in terms of identifying the dominant emotion and level of emotional arousal they experience while viewing each image. A memory recognition test administered at T2 and session 3 (Time 3; T3, 20 minutes durations) will serve to test for consolidation and reconsolidation of the affective images respectively.

The IAPS is a collection of thousands of images tested in multiple large scale trials in order to be standardised according to arousal and valence of emotions felt. We selected a portion of these according to the type of emotion they elicit. The images range from children playing/kittens (joy) to mutilated bodies/excrement (disgust).

Prior to the memory task (T1) Group A will receive an oral dose of short-acting (SA) propranolol at a dose of 1mg/kg, while the other two groups will receive a placebo. At T2, only Group B will receive SA propranolol (1mg/kg) prior to the recognition task, while the other two groups will receive a placebo. At Session 3, no medication (or placebo) will be administered to any group.
Intervention code [1] 291532 0
Treatment: Drugs
Intervention code [2] 291533 0
Behaviour
Comparator / control treatment
During the first two sessions, participants not receiving Propranolol will be receiving a non-active placebo (lactose monohydrate capsule) in the same colour and dose capsules used for Propranolol.

The purpose of administering a placebo is to maintain the double-blinded nature of the study: so as not to divulge to participants or investigators whether they are taking active treatment or not.
Control group
Placebo

Outcomes
Primary outcome [1] 294689 0
Memory recognition task performance for images depicting different basic emotions (% correct for previously seen images).
Timepoint [1] 294689 0
At T2 (week 2) and T3 (week 3)
Primary outcome [2] 294690 0
Changes in subjective ratings of emotional arousal to pictorial stimuli representing different basic emotional dimensions, using the Self-Assessment Manikin (SAM) scale ratings.
Timepoint [2] 294690 0
Recorded at T1 (week 1) and T2 (week 2).
Secondary outcome [1] 313865 0
Reaction time measures of memory recognition taken during memory recognition task.
Timepoint [1] 313865 0
Measured at T2 (week 2) and T3 (week 3).

Eligibility
Key inclusion criteria
a. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study;
b. Male or female subjects aged 18 to 65 years at the time of consent;
c. Female subjects must not be childbearing or of childbearing potential (i.e., they must be either surgically sterile, under an acceptable method of birth control, fully sexually abstinent or be one year post last menstrual period). Female subjects must meet all of the following criteria:
*Agree to avoid pregnancy during the study;
*Use one of the birth control methods listed below for the duration of the trial. Preferred methods of birth control include:
i. An oral contraceptive agent, implantable contraceptive (e.g., Norplant) or an injectable contraceptive (e.g., Depo Provera) for at least one month prior to entering the study or prior to having sexual relations during the study and will continue its use throughout the study, or
ii. An intrauterine device, or
iii. Partner has had a vasectomy at least 3 months prior to study start.
*Also allowed:
i. A latex condom
ii. A double barrier method of a diaphragm with spermicide, plus a latex condom, or
iii. Agree to abstain from sex for the duration of the trial;
d. Individuals who consent to remain abstinent from all drugs of abuse (except nicotine) for 24 hours prior to enrolment;
e. Individuals treated with the following medications must be on stable doses for at least 1-month prior to the screening visit and during the entire study: anxiolytics, sedatives, hypnotics, antidepressants, antipsychotics;
f. Individuals taking Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin–Norepinephrine Reuptake Inhibitors (SNRIs), such as venlafaxine, must accept to skip their morning dose the day of each study visit;
g. Individuals shall not start taking new medications on a regular basis during the study. Case-by-case decisions will be made in collaboration with the study physician regarding participants who cannot comply with this criterion;
h. Fluency in French or English;
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
a. Systolic blood pressure <100 mm Hg;
b. Cardiac rhythm below 55 beats per minute;
c. A medical condition that contraindicates the administration of propranolol, e.g., Asthma, chronic obstructive pulmonary disease, cardiac insufficiency, second- or third-degree atrioventricular block, spastic angina, auricular sinus illness, bradycardia, Raynaud’s disease, severe peripheral vascular disease, untreated Pheochromocytoma, arterial hypotension, previous anaphylactic allergic shock;
d. Previous adverse reaction to, or non-compliance with, beta-blocker;
e. Current use of medication that may involve potentially dangerous interactions with propranolol, including, other beta-blockers, antiarrhythmics, calcium channel blockers, and Potent P450 2D6 inhibitors, (e.g., fluoxetine, paroxetine, miconazole, sulconazole, metoclopramide, quinidine, ticlopidine, and ritnavir), clonidine, insulin, sulfonylureas, lidocaine, iodine contrast agents for medical imaging, imipramine or tricyclic antidepressants. SSRIs and SNRIs are may be used during the study (see inclusion criteria f);
f. Women who are pregnant or breast feeding;
g. The following psychiatric conditions: Past or present bipolar disorder or psychosis;
h. Individuals with a substance dependence or substance abuse problem;
i. Subjects judged (based on history, mental status exam, or clinical impression, as being at significant risk of self-injurious/suicidal behaviour;
k. Subjects having received a previous or present diagnosis of post-traumatic stress disorder (PTSD);
l. Participation in another drug trial within 30 days prior to the screening visit or during the study;
m. Any condition that can significantly affect the absorption of the study medication.
n. Presence of any clinical or medical condition that might interfere with the interpretation of the efficacy and safety results.
o. Previous exposure/familiarity to IAPS. Individuals participating in this study cannot be familiar with the IAPS as having any previous memory of the pictorial stimuli shown during the experiment could have an effect on the scientific validity of the study results.
p. If you the participant is easily affected by emotionally stimulating images.

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)
Allocation was concealed using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization.
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 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/03/2015
Date of last participant enrolment
Anticipated
Actual
1/06/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
45
Recruitment outside Australia
Country [1] 6783 0
Canada
State/province [1] 6783 0
Quebec

Funding & Sponsors
Funding source category [1] 291020 0
Self funded/Unfunded
Name [1] 291020 0
Personal funds obtained from running i-Trauma website at McGill University and the Douglas Mental Health Institute
Country [1] 291020 0
Canada
Funding source category [2] 291021 0
University
Name [2] 291021 0
The University of Melbourne
Country [2] 291021 0
Australia
Primary sponsor type
Individual
Name
Alain Brunet, PhD
Address
Douglas Mental Health University Institute
6875 Blvd Lasalle
Verdun, Quebec (H4H 1R3)
Country
Canada
Secondary sponsor category [1] 289697 0
Individual
Name [1] 289697 0
Ariel Dahan, BSc, MSc Candidate - McGill University, MD Candidate - University of Melbourne
Address [1] 289697 0
Douglas Mental Health University Institute (Affiliated with McGill University)
6875 Blvd Lasalle, Perry Pavillion Room E-3120
Verdun, Quebec (H4H 1R3)
Country [1] 289697 0
Canada
Other collaborator category [1] 278412 0
Hospital
Name [1] 278412 0
Douglas Mental Health University Institute
Address [1] 278412 0
Douglas Mental Health University Institute
6875 Blvd Lasalle
Verdun, Quebec (H4H 1R3)
Country [1] 278412 0
Canada
Other collaborator category [2] 278413 0
University
Name [2] 278413 0
McGill University, Department of Psychiatry
Address [2] 278413 0
Ludmer Research & Training Building
1033 Pine Avenue West
Montreal, QC, H3A 1A1
Country [2] 278413 0
Canada
Other collaborator category [3] 278414 0
University
Name [3] 278414 0
Melbourne Medical School, The University of Melbourne
Address [3] 278414 0
Department of Medical Education, Melbourne Medical School
Level 7 North, Medical Building
The University of Melbourne VIC 3010
Country [3] 278414 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292603 0
Douglas Insitute Research Ethics Board
Ethics committee address [1] 292603 0
Ethics committee country [1] 292603 0
Canada
Date submitted for ethics approval [1] 292603 0
Approval date [1] 292603 0
06/03/2015
Ethics approval number [1] 292603 0
11/48

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

Contacts
Principal investigator
Name 56194 0
A/Prof Alain Brunet, PhD
Address 56194 0
Douglas Mental Health University Institute
6875 LaSalle Blvd
Montreal, Quebec
H4H 1R3
Country 56194 0
Canada
Phone 56194 0
+1-514-761-6131 ext. 4348
Fax 56194 0
Email 56194 0
[email protected]
Contact person for public queries
Name 56195 0
Ariel Dahan, BSc
Address 56195 0
Douglas Mental Health University Institute
6875 Blvd Lasalle, Perry Pavillion Room E-3120
Montreal, Quebec
H4H 1R3
Country 56195 0
Canada
Phone 56195 0
+1-514-761-6131 ext. 3337
Fax 56195 0
Email 56195 0
[email protected]
Contact person for scientific queries
Name 56196 0
Ariel Dahan, BSc
Address 56196 0
Douglas Mental Health University Institute
6875 Blvd Lasalle, Perry Pavillion Room E-3120
Montreal, Quebec
H4H 1R3
Country 56196 0
Canada
Phone 56196 0
+1-514-761-6131 ext. 3337
Fax 56196 0
Email 56196 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

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