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Depressed Mood Improvement Through Nicotine Dosing (Depressed MIND Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02816138
Recruitment Status : Completed
First Posted : June 28, 2016
Results First Posted : September 27, 2018
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Warren Taylor, Vanderbilt University Medical Center

Brief Summary:

Late-life depression is characterized by both affective (mood) symptoms and cognitive deficits. There is currently no intervention that may provide consistent benefits to both mood and cognitive performance. Agonist activity at the nicotinic acetylcholine receptors via transdermal nicotine patches may provide benefit to both mood and cognition, working through nicotine's effects on brain neural networks, specifically the cognitive control network and default mode network.

In this initial pilot project, the investigators will test this hypotheses in 15 nonsmoking depressed elders with subjective cognitive impairment. Following baseline neuroimaging and cognitive testing, participants will receive 12 weeks of open-label transdermal nicotine. Afterwards, participants will repeat neuroimaging and cognitive assessments.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Nicotine Phase 4

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Depressed Mood Improvement Through Nicotine Dosing (Depressed MIND Study)
Actual Study Start Date : October 2016
Actual Primary Completion Date : August 23, 2017
Actual Study Completion Date : September 12, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transdermal nicotine patch
Transdermal nicotine patch, administered on awakening and removed at bedtime (16h/d). Dosing 3.5mg patch/daily, titrated over study to maximum dose of 21mg patch/daily.
Drug: Nicotine
Open-label transdermal nicotine patch
Other Names:
  • Nicotrol
  • Nicoderm CQ




Primary Outcome Measures :
  1. Change in Total MADRS (Montgomery Asberg Depression Rating Scale) Score [ Time Frame: Baseline to week 12 ]
    Primary mood outcome measured by the total score of the clinician-rated MADRS. MADRS was measured every 3 weeks (baseline, week 3, week 6, week 9, and week 12). MADRS total score range is 0-60, where higher scores indicate greater depression severity.

  2. Change in Continuous Performance Task (CPT) Performance [ Time Frame: Baseline to week 12 ]
    Primary cognitive outcome, the CPT is a neuropsychological test that measures attention. In this 14-minute test, participants are asked to respond when any letter appears, except the non-target letter "X". This test is conducted at baseline and at week 12. The specific primary outcome metric is standard error of change in the inter-stimulus hit reaction time, or variability between different trials. There is no absolute range, but lower scores indicate decreased variability across trials and overall better performance.


Secondary Outcome Measures :
  1. Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score [ Time Frame: Baseline to week 12 ]
    Secondary mood outcome: Change in anhedonia measured by SHAPS, a self-report questionnaire that ranges from 0-42, where higher scores indicate greater anhedonia.

  2. Change in Penn State Worry Questionnaire (PSWQ) [ Time Frame: Baseline to week 12 ]
    Secondary mood outcome: Change in anxiety and worry measured by PSWQ, a self-report questionnaire with a range of 16-80, where higher scores indicate greater anxiety and worry.

  3. Change in Ruminative Response Scale Total Score [ Time Frame: Baseline to week 12 ]
    Secondary mood outcome: Change in rumination measured by the Ruminative Response Scale total score measured at baseline and week 12. This is a self-report scale with a range of 0-66, where higher scores indicate higher levels of rumination.

  4. Change in Apathy Evaluation Scale (AES) [ Time Frame: Baseline to 12 weeks ]
    Secondary Mood Outcomes: Change in apathy as measured by the self-report AES, a questionnaire with a range of 0-54, where lower scores indicate greater apathy.

  5. Change in MFQ (Memory Frequency Questionnaire) Score [ Time Frame: Baseline to week 12 ]
    Secondary cognitive outcome: Change in subjective cognitive performance as measured by MFQ, a self-report scale ranging from 64-448. Higher scores indicate better subjective memory function, while lower scores indicate poorer subjective memory function.

  6. Change in Choice Reaction Time (CRT) Performance [ Time Frame: Baseline to week 12 ]
    Secondary cognitive outcome, a neuropsychological test measure of attention. We examined the total response time for the CRT. Lower scores indicate better performance.

  7. Change in One-back Test Performance [ Time Frame: Baseline to week 12 ]
    Secondary cognitive outcome examining change in speed of responses ton the one-back test, no absolute range. In this variant of the "N-back" task, participants view a series of cards, and indicate whether the card they are currently viewing is identical to the previously viewed card. Lower scores indicate better performance.

  8. Change in NYU (New York University) Paragraph Recall Performance [ Time Frame: Baseline to week 12 ]
    Secondary cognitive outcome of a neuropsychological test examining episodic memory performance using the NYU Paragraph Recall test. No absolute range. Higher scores indicate better performance.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 60 years;
  • DSM-5 (Diagnostic and statistical manual-5) diagnosis of major depressive disorder, single or recurrent episode;
  • Subjective cognitive decline, defined as endorsing 20% of items on the Cognitive Complaint Index (CCI);
  • depression severity: MADRS (Montgomery-Asberg Depression Rating Scale) ≥ 15;
  • cognition: MOCA (Montreal Cognitive Assessment) ≥ 24;
  • fluent in English;
  • intact hearing / vision allowing completion of study procedures;
  • for individuals on antidepressants at study entry, they must be on a stable dose for at least 6 weeks.

Exclusion Criteria:

  • Other Axis I psychiatric disorders, except for anxiety symptoms occurring in a depressive episode;
  • History of alcohol or drug dependence or abuse in the last 3 years;
  • Tobacco or nicotine use in last year;
  • History of a developmental disorder or IQ score < 70;
  • Acute suicidality;
  • Acute grief (<1 month);
  • Current or past psychosis;
  • Primary neurological disorder, including dementia, stroke, brain tumors, etc.;
  • Any MRI contraindication;
  • Unstable medical illness;
  • Allergy or hypersensitivity to nicotine patches;
  • Regular use of drugs with centrally acting cholinergic or anticholinergic properties in last 4 weeks, including acetylcholinesterase inhibitors;
  • Current or planned psychotherapy;
  • Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) in last two months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02816138


Locations
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United States, Tennessee
Vanderbilt Psychiatric Hospital
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Warren D Taylor, MD, MHSc Vanderbilt University Medical Center
  Study Documents (Full-Text)

Documents provided by Warren Taylor, Vanderbilt University Medical Center:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Warren Taylor, Associate Professor of Psychiatry, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02816138    
Other Study ID Numbers: DepMIND
First Posted: June 28, 2016    Key Record Dates
Results First Posted: September 27, 2018
Last Update Posted: September 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Warren Taylor, Vanderbilt University Medical Center:
Geriatrics
Depression
Elderly
Cognition
Memory
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action