Clinical Trials

 

 

What is a clinical trial?

A clinical trial is a research study performed in people aiming to evaluate the effectiveness of a treatment; treatments can include medication, psychological therapy, neuromodulation or other types of therapy.

 

Why participate in a clinical trial?

Like all treatment options, clinical trials have possible benefits and risks. Clinical trials offer access to new treatments and participants contribute to new knowledge that many benefit others. Our clinical trials team will provide all the necessary information regarding potential risks and benefits to enable participants to make the decision that is best for them.

 

 

Augmentation versus Switch: Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders with Treatment Resistant Depression (ASCERTAIN-TRD)

Project Lead: Dr. Fidel Vila-Rodriguez, Assistant Professor of Psychiatry, UBC
Funding: Patient-Centred Outcomes Research Institute (PCORI)
Years: 4

This is a multi-site open-label trial comparing the effectiveness of three treatments in patients with treatment-resistant major depressive disorder who are on ongoing, stable, and adequate antidepressant therapy. Patients will be randomized to either aripiprazole augmentation, or augmentation with repetitive transcranial magnetic stimulation (rTMS) or switching to venlafaxine or duloxetine. rTMS is a non-invasive neuromodulation treatment. Aripiprazole, venlafaxine, and duloxetine are medications that have been approved for the treatment of depression. This study has been approved by the UBC Ethics Committee. For more information, please email ninet.lab@ubc.ca or afifa.humaira@ubc.ca; call Afifa Humaira at 604-822-7308; or visit https://ninet.med.ubc.ca

 

Patient-Oriented Randomized Pragmatic Feasibility Trial with rTMS in Depression and Anxiety (PORT)

Project Lead: Dr. Fidel Vila-Rodriguez, Assistant Professor of Psychiatry, UBC
Funding: Michael Smith Foundation for Health Research (MSFHR)
Years: 2020-2025

This trial compares the efficacy of two different neuromodulation treatments, intermittent theta-burst stimulation (iTBS) and low frequency repetitive transcranial magnetic stimulation (rTMS), for depression and anxiety symptoms in patients with treatment resistant depression (TRD), who are diagnosed with either major depressive disorder or bipolar disorder. Participants will be randomized to receive either iTBS or low frequency rTMS. This study also involves assessments of mood, blood smears, and cognitive assessments. This study is pending approval from the UBC Ethics Committee. For more information, please email ninet.lab@ubc.ca or afifa.humaira@ubc.ca; call Afifa Humaira at 604-822-7308; or visit https://ninet.med.ubc.ca

 

Left Intermittent Theta Burst Stimulation vs. Right Low Frequency Repetitive Transcranial Magnetic Stimulation Effectiveness in Depression and Suicidal Ideation: A Randomized Non-Inferiority Trial (LeRNIT)

Project Lead: Dr. Fidel Vila-Rodriguez, Assistant Professor of Psychiatry, UBC
Funding: Canadian Institutes of Health Research (CIHR)
Years: 2020-2025

The purpose of this trial compares the efficacy of two non-invasive neuromodulation treatments, low frequency repetitive transcranial magnetic stimulation (rTMS) and intermittent theta burst stimulation (iTBS), in treating patients with Major Depressive Disorder and suicidal ideation. Participants will be randomized to receive either daily iTBS or daily rTMS over 6 weeks. The study includes assessments of mood, MRI brain scan, recording of heart rhythm (ECG), cognitive assessments. This study is pending approval from the UBC Ethics Committee. For more information, please email ninet.lab@ubc.ca or afifa.humaira@ubc.ca; call Afifa Humaira at 604-822-7308; or visit https://ninet.med.ubc.ca

 

Additional information about clinical trials in Major Depressive Disorder can be found at the following website:

https://mood.med.ubc.ca/clinical-research-programs/unipolar-depression-studies/

 

 

Cognitive outcomes and the Response/Remission Efficacy of Convulsive Therapies in Bipolar Depression (CORRECT-BD)

Project Lead: Dr. Fidel Vila-Rodriguez, Assistant Professor of Psychiatry, UBC
Funding: Brain Canada
Years: 2018-2022

This study investigates a new non-invasive neurostimulation technique, Magnetic Seizure Therapy (MST), as an alternative to electroconvulsive therapy (ECT) for bipolar depression. We are seeking patients diagnosed with bipolar disorder who are currently depressed and are willing to receive brain stimulation treatments under general anesthesia. This study involves clinical questionnaires, cognitive assessments, measurement of brain waves (EEG), bi-weekly ECT or MST treatments. The study also involves regular monitoring visits and one follow-up visit 6 months after treatment. Participants will be remunerated. This study has been approved by Health Canada and the UBC Ethics Committee. For more information, please email ninet.lab@ubc.ca or michelle.avina@ubc.ca; call Michelle Avina at 604-822-7308; or visit https://ninet.med.ubc.ca

 

Cognitive outcomes and the Response/Remission Efficacy of Convulsive Therapies during Continuation (CORRECT-C)

Project Lead: Dr. Fidel Vila-Rodriguez, Assistant Professor of Psychiatry, UBC
Funding: Brain Canada
Years: 2018-2022

This study is a continuation of the CORRECT-BD trial and is only open to patients who have successfully enrolled in CORRECT-BD. The study compares the effectiveness of brain stimulation treatments - Magnetic Seizure Therapy (MST) and electroconvulsive therapy (ECT), in maintaining clinical improvement. This study involves clinical questionnaires, cognitive assessments, measurement of brain waves (EEG), ECT or MST treatments under general anesthesia, regular monitoring visits, and one follow-up visit after treatment. Participants will be remunerated. This study has been approved by Health Canada and the UBC Ethics Committee. For more information, please email ninet.lab@ubc.ca or michelle.avina@ubc.ca; call Michelle Avina at 604-822-7308; or visit https://ninet.med.ubc.ca


Efficacy of Cariprazine in Improving Cognitive Functioning in Euthymic patients with Bipolar I Disorder: A Proof of Concept Randomized, Double Blind Placebo Controlled Trial

Principal investigator: Dr. Lakshmi Yatham, Professor of Psychiatry, UBC
Funding: Grant  - Allergen Inc.
Years: 2021-2026
UBC CREB: (#H20-01293)

This study is tests whether adding Cariprazine to current medication in people diagnosed with bipolar disorder improves cognitive abilities (for example, attention, memory) over a 6-week period compared to a placebo. Cariprazine is a medication approved for the treatment of bipolar disorder in the USA which may also help with any associated cognitive difficulties.  We are looking for patients diagnosed with bipolar disorder who are not currently experiencing a mood episode, are 19-65 years of age, and are clinically stable on current medication. The study involves clinical questionnaires, and tests of memory, reasoning and attention. Compensation will be provided for participation. The study has been approved by the UBC Ethics Committee (# H20-01293). For more information, please email jayasree.basivireddy@ubc.ca or call Jayasree at 604-822-3769.

More information can also be found at https://www.vchri.ca/research-study/assessing-role-cariprazine-improving-cognition-euthymic-bipolar-patients-carpz-01 and ClinicalTrials.gov.

 

 

Investigating individual functional targets to treat mild cognitive impairment with repetitive transcranial magnetic stimulation (FIRM)

Project Lead: Dr. Fidel Vila-Rodriguez, Assistant Professor of Psychiatry, UBC
Funding: Dawn Shaw Alzheimer's Disease Research Grant
Years: 2021-2022

This study examines the effect of a non-invasive brain stimulation procedure, repetitive transcranial magnetic stimulation (rTMS) for improving thinking abilities in people with memory problems. The rTMS treatment will be personalized for each participant based on their brain scan.  We are seeking individuals aged 55 year or older diagnosed with amnestic-type mild cognitive impairment. Participants should have a carer who would be able to accompany them to all study visits. This study involves clinical questionnaires, cognitive assessments, brain scans (MRI), brain wave measurements (EEG), and daily rTMS treatments, and follow-up visits 1-week and 3-months after treatment. Participants will be remunerated. This study has been approved by the UBC Ethics Committee. For more information, please email ninet.lab@ubc.ca or quincy.beck@ubc.ca; call Quincy Beck at 604-822-7308; or visit https://ninet.med.ubc.ca

 

Magnetic Seizure Therapy for Parkinson’s Disease (MST for PD)

Project Lead: Dr. Fidel Vila-Rodriguez, Assistant Professor of Psychiatry, UBC
Funding: 2021-2022
Years: Weston Brain Institute

This study investigates a new non-invasive neurostimulation technique, Magnetic Seizure Therapy (MST), for the treatment of depression in patients with Parkinson’s disease. We are seeking patients aged 50 years or older, who are diagnosed with Parkinson’s disease and are currently depressed. This study involves clinical questionnaires, cognitive assessments, measurement of brain waves (EEG), activity tracking (actigraphy), and bi-weekly MST treatments under general anesthesia. The study also involves regular monitoring visits and a follow-up visit 1 month after treatment. Participants will be remunerated. This study has been approved by Health Canada and the UBC Ethics Committee. For more information, please email ninet.lab@ubc.ca or michelle.avina@ubc.ca; call Michelle Avina at 604-822-7308; or visit https://ninet.med.ubc.ca