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CARED : A Novel Rapid Treatment Paradigm for Depression

ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of North Carolina, Chapel Hill

About this trial

The purpose of this study is to primarily assess the feasibility and secondarily assess the efficacy of a single session intervention (SSI) that combines non-invasive brain stimulation and psychotherapy for Major Depressive Disorder (MDD). investigators will recruit 30 people with MDD, with at least mild to moderate symptoms, who are resistant to typical treatments for Major Depressive Disorder. In this trial, participants will receive psychotherapy, Intermittent Theta Burst Stimulation Transcranial Magnetic Stimulation (iTBS), and either active or sham (placebo) Transcranial Alternating Current Stimulation (tACS).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Any gender, aged 18 - 70

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

DSM-5 diagnosis of unipolar, non-psychotic MDD as evidenced by the Diagnostic Interview for Anxiety, Mood, and Obsessive-Compulsive and Related Neuropsychiatric Disorders (DIAMOND)

Disqualifiers

DSM-5 diagnosis of severe alcohol use disorder (AUD) within the last 12 months, as evidenced by the DIAMOND

DSM-5 diagnosis of moderate to severe substance use disorder (excluding tobacco) within the last 12 months, as evidenced by the DIAMOND

Lifetime history of bipolar disorder, as evidenced by DIAMOND

Schizophrenia spectrum and other psychotic disorders, as evidenced by DIAMOND

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intermittent Theta Burst Stimulation (iTBS)

    Device

    The TMS stimulation will be delivered using the MagPro X100 system (MagVenture Inc., Alpharetta, Georgia, USA). Participants will receive theta-burst stimulation (iTBS) consisting of 1,800 biphasic pulses delivered in bursts of three pulses at 50 Hz, repeated at 5 Hz (2-s trains, 8-s inter-train interval, 30 trains total per block), at an intensity of 90 % of the resting motor threshold. TMS will be delivered before each tACS/therapy block (over the tACS electrodes), totaling 5 blocks of TMS throughout the single session intervention.

  • Transcranial Alternating Current Stimulation (tACS)

    Device

    The alpha and -theta tACS stimulation will be delivered using the neuroConn DC Stimulator MC.The interventional tACS stimulation will be 120 minutes of tACS total; 60 minutes will be delivered during the second block of therapy and 60 minutes will be delivered during the third block of therapy.F3 and F4 will be stimulated 'in-phase', with 1 mA applied at each location, and Cz will be stimulated 'anti-phase' with 2mA applied (zero to peak). tACS will be delivered with a 20 second ramp up and ramp down, at the beginning and end of stimulation. The stimulation amplitude delivered is standard for tACS studies conducted in the Frohlich Lab.

  • Psychotherapy

    Behavioral

    The three, 1-hour psychotherapy blocks were designed to incorporate effective components from multiple psychotherapies, with an emphasis on functional analysis to define the presenting concern, followed by Behavioral Activation (BA) and Acceptance and Commitment Therapy modules to target low mood and psychological flexibility, respectively. The SSI was designed to incorporate ACT principles throughout the modules, guided by the tenets of psychological flexibility, as described by Hayes. Be present, open up, do what matters. The manual was created by a team of several advanced clinical trainees and two licensed clinical psychologists. The last 10 minutes of each session will be spent briefly reviewing the day's activities, what stood out for participants (negative or positive), and whether they had feedback for the clinician.

  • Sham (Placebo) Transcranial Alternating Current Stimulation (tACS)

    Device

    Participants will be fitted with the same tACS setup and will receive sham tACS in which alpha-theta tACS is delivered for 40 seconds before ramping down to close to 0 mA of current (20 second ramp up and ramp down; total 80 seconds of stimulation). This active sham is designed to mimic the sensation of receiving stimulation without delivering a sufficient dose of tACS to influence the efficacy of the SSI.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Inactive Sham (Placebo)Active comparator 3 interventions
Group B: Active tACS: Experimental ArmExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Safety via the presence of any serious AEs

The number of serious adverse events (SAEs) determined to be related to intervention in both experimental and sham arms.

Time frame
Day 0 (Baseline) to Day 90 (Follow-up 2)
2

Feasibility of the Single Session Intervention

Number of enrolled participants who successfully complete the intervention session.

Time frame
Day 0 (Baseline)

Secondary outcomes

1

Change in Hamilton Depression Rating Scale-17 (HDRS-17) score following Single Session Intervention.

The HDRS-17 is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 52. A higher score indicates a worse outcome. Investigators will determine the change in scores across the intervention from Day 0 (Baseline) to Day 14 (Follow-up 1).

Time frame
Day 1 (Baseline) to Day 14 (Follow-up 1)
2

Duration of change in Hamilton Depression Rating Scale-17 (HDRS-17) score following Single Session Intervention.

The HDRS-17 is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 52. A higher score indicates a worse outcome. Investigators will determine the change in scores between Day 14 (Follow Up 1) to Day 90 (Follow-up 2) to establish the longevity of treatment effectiveness (if effective) via Follow Up timepoints overall and for both arms.

Time frame
Day 14 (Follow Up 1) to Day 90 (Follow-up 2)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

Foundation of Hope, North Carolina

Collaborator

Source ClinicalTrials.gov
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