Meditation for Depression

• Register: ClinicalTrials.gov
• Last refreshed on: 25 January 2021
• Main ID: NCT01671436
• Date of registration: 20/08/2012
• Prospective Registration: Yes
• Primary sponsor: University of California, San Francisco
• Public title: Meditation for Depression CMIT
• Scientific title: Central Meditation and Imagery Therapy for Depression
• Date of first enrolment: September 2012
• Target sample size: 13
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01671436
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Felipe Jain, M.D.
• Affiliation: University of California, Los Angeles

Key inclusion & exclusion criteria

Inclusion Criteria:

- Meeting the DSM-IV criteria for unipolar major depressive disorder, as assessed by the
Mini-Neuropsychiatric International Interview (MINI).

- HAM-D17 rating scale = 14.

- Prior treatment with antidepressant medication during the present major depressive
episode

- Adequate written and oral fluency in English to understand and complete study forms
and converse with study personnel.

- Willingness on part of both subject and treating clinician to not change
antidepressant treatment, including medications, psychotherapy or other treatments,
over the course of the study, unless necessary to provide for well being of subject.

Exclusion Criteria:

- Current diagnosis of schizophrenia or any psychotic disorder including psychotic
depression, dysthymia, mania or bipolar disorder, attention deficit or hyperactivity
disorder, generalized anxiety disorder or panic disorder, obsessive compulsive
disorder, alcohol or drug dependence, mental retardation, any pervasive developmental
disorder or cognitive disorder (according to DSM-IV) criteria. Those with lifetime
history of psychiatric conditions other than unipolar major depression will be also
excluded.

- Medically unstable, delirious, or terminally ill (e.g. medical illness requiring
hospitalization or intense outpatient management, such as heart disease; heart attack
in the past 6 months; congestive heart failure; severe heart arrythmias; unstable
hypertension; poorly controlled diabetes; or pending surgery).

- Past history of skull fracture; cranial surgery entering the calvarium; space
occupying intracranial lesion; stroke/ aneurysm; Parkinson's or Huntington's disease;
or Multiple Sclerosis.

- Participants regularly practicing (= 2 times per week) any of the techniques utilized
in the study to reduce stress: meditation, guided imagery, yoga.

- Current treatment with behavior therapy or psychotherapy.

- Active suicidal plan as measured by HAM-D item 3 score of greater than or equal to 3,
or history of suicide attempt during the current episode.

- Utilization of cannabis or other illicit drugs more than once a month.

- Excessive use of alcohol, i.e., men whose alcohol consumption exceeds 14 standard
drinks per week or 4 drinks per day, and women whose alcohol consumption exceeds 7
standard drinks per week or 3 drinks per day.

- Needing to adjust or change anti-depressant treatment, including medications,
psychotherapy, repetitive Transcranial Magnetic Stimulation (rTMS), Electroconvulsive
Therapy (ECT), or Vagus Nerve Stimulation (VNS).



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Depression

Intervention(s)

Behavioral: Central Meditation and Imagery Therapy

Primary Outcome(s)

Hamilton Rating Scale for Depression (HAM-D) [Time Frame: Measured 4 times over 12 weeks]

Secondary Outcome(s)

Quick Inventory of Depressive Symptoms- Self Report (QIDS- SR) [Time Frame: Weekly assessments measured over 12 weeks, and 2 month follow-up]

Secondary ID(s)

CMIT-1042

Source(s) of Monetary Support

Please refer to primary and secondary sponsors