Ketamine and Behavioural Activation Therapy study

Not Applicable

Recruiting

• Conditions: Treatment Resistant Depression; Mental Health - Depression

• Registration Number: ACTRN12623000817640
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-28
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Participants aged between 18 and 65 years with treatment-resistant, DSM 5, Major Depressive Disorder (TR-MDD) are eligible for entry to the study. A standard definition for treatment resistance will be used: having trialled, and not responded to, at least two antidepressant medications at adequate doses for more than 6 weeks.

At screening, patients will have a Hamilton Depression Rating Scale-17 (HAMD) greater than 16, reflecting depression of at least moderate severity.

Participants will be required to be on stable medication treatment (or no treatment) for at least 1 month prior to screening for the study and commit to remaining on the same medication during active treatment to ensure treatment withdrawal or dose changes do not confound study effects.

Proficient in spoken English

Exclusion Criteria

Evidence of severe acute or chronic medical conditions (e.g. diabetes, ischaemic heart disease, chronic obstructive airways disease, cerebro-vascular disease);

Past or current diagnoses of schizophrenia, bipolar disorder, or current psychotic symptoms; moderate-severe personality disorder;

Current or recent significant suicidal ideation;

Current or recent (past 6 months) substance use disorder;

Prior history of seizures; susceptibility to photosensitivity; or a history of allergic skin reactions; prior history of serious head injury or other neurological condition resulting in ongoing cognitive impairment;

Participants who are breast feeding or pregnant

Receiving active psychotherapy for MDD (supportive psychotherapy can be placed on hold during the study)

Having received a course of BAT in the last 12 months; previous non-response to BAT or Ketamine treatment

Electro-Convulsive Therapy (ECT) in the last 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified