Phase 4
N=15
Depressed Mood Improvement Through Nicotine Dosing (Depressed MIND Study)
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02816138 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Change in Total MADRS (Montgomery Asberg Depression Rating Scale) Score — -18.45 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nicotine (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total MADRS (Montgomery Asberg Depression Rating Scale) Score |
-18.45 | <0.001 sig |
| PRIMARY Change in Continuous Performance Task (CPT) Performance |
-0.003 | 0.761 |
| SECONDARY Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score |
-3.4 | 0.084 |
| SECONDARY Change in Penn State Worry Questionnaire (PSWQ) |
-5.1 | 0.073 |
| SECONDARY Change in Ruminative Response Scale Total Score |
-9.0 | 0.002 sig |
| SECONDARY Change in Apathy Evaluation Scale (AES) |
7.7 | <0.001 sig |
| SECONDARY Change in MFQ (Memory Frequency Questionnaire) Score |
23.64 | 0.049 sig |
| SECONDARY Change in Choice Reaction Time (CRT) Performance |
-16.0 | 0.502 |
| SECONDARY Change in One-back Test Performance |
-0.040 | 0.049 sig |
| SECONDARY Change in NYU (New York University) Paragraph Recall Performance |
3.4 | 0.068 |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02816138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.