Depression Clinical Trial
— DEP-CIOfficial title:
Pilot Combination Treatment Trial of Mild Cognitive Impairment With Depression
Verified date | October 2017 |
Source | New York State Psychiatric Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients presenting with depression (DEP) and cognitive impairment (CI), represent a unique,
understudied population that is difficult to diagnose, treat and estimate prognosis. Our
pilot data, supported by the literature, suggest that many DEP-CI patients show cognitive
decline and often convert to dementia, primarily Alzheimer's disease (AD). In DEP-CI, there
is a lack of data on treatment response of mood symptoms to antidepressant treatment and
particularly of cognitive deficits to cognitive enhancer treatment. Our initial pilot data in
a double-blind study showed that donepezil was superior to placebo in improving memory in
antidepressant-treated DEP-CI patients. In a second pilot study, open label es-citalopram
plus memantine treatment led to a low rate of conversion to dementia.
In this proposed pilot clinical trial, the investigators will evaluate, treat and follow a
broad sample of 80 DEP-CI patients at NYSPI/Columbia University Medical Center (N = 40) and
Duke University Medical Center (N = 40). Recruitment will be from clinics and/or
advertisements. In the treatment protocol, all 80 DEP-CI patients will receive baseline mood
and memory assessments and open antidepressant treatment with citalopram for 8 weeks. At 8
weeks, repeat assessment will occur and patients whose depression has responded to citalopram
will be randomized to add-on donepezil or placebo. Non-responders to citalopram will receive
open treatment with venlafaxine and will be randomized 8 weeks later (16 weeks of open
antidepressant treatment) to add-on donepezil or placebo. Patients will be followed for a
total period of 18 months with continuous open antidepressant treatment during the trial.
Donepezil is being studied in order to increase the likelihood of obtaining a signal. If the
results are positive, the investigators can begin clarifying the mechanism(s) in subsequent
trials. Baseline apolipoprotein E e4 genotype, odor identification deficits, and MRI
hippocampal and entorhinal cortex atrophy will be explored as predictors of donepezil
response in the 18-month trial. Improving cognition and delaying conversion to a clinical
diagnosis of dementia in this high risk group will enhance quality of life, reduce family
burden, and markedly diminish overall health care costs.
Status | Completed |
Enrollment | 86 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 95 Years |
Eligibility |
Inclusion Criteria: - Of either sex, age 55-95 years old with minimum 8 years of education who meet criteria for both depression and cognitive impairment as described below. - Study Criteria for "depression": i. Patients who meet DSM-IV symptom criteria for Major Depression or Dysthymia for a minimum of 6 months (2 year duration DSM-IV TR criterion not required for dysthymic disorder in this study). ii. 24-item HAM-D =14. - Study Criteria for "cognitive impairment": i. Subjective memory or other cognitive complaints. ii. Score = 11 on the Logical Memory II (Delayed Paragraph Recall, Paragraph A) test from the Wechsler Memory Scale - Revised OR a score that is = 1.5 standard deviations below the norms on the FC SRT - Folstein Mini Mental State (MMSE) score = 21 out of 30. - Clinical Dementia Rating (CDR) of 0.5 on the memory item and global rating of 0.5 indicating questionable dementia - Willing and capable of giving informed consent - A family member or close friend who consents to serve as informant during the study; this can be a telephone informant in the case of patients who do not have a live-in informant or close significant other. Exclusion Criteria: - Meets Criteria for dementia (DSM-IV) or probable Alzheimer's disease (NINCDS-ADRDA criteria) - Meets DSM IV TR criteria for: 1. schizophrenia, schizoaffective disorder, psychotic depression or other psychosis, or bipolar I disorder 2. alcohol or substance dependence or abuse (current or within past 6 months) - Active suicidal ideation or suicidal attempt in last 6 months. - Clinical stroke with residual neurological deficits. - Use of medications known to have a negative impact on cognition: benzodiazepines in lorazepam equivalents = 2 mg daily, narcotics, or anticholinergics. (N.B. Medications that may be associated with cognitive impairment but are rarely considered the likely etiology, e.g, theophylline, nifedipine, Beta blockers, will not be excluded.) - An acute, severe or unstable medical condition. For cancer, acutely ill patients (including those with metastases) are excluded, but past history of successfully treated cancer does not result in exclusion. - Presence of any of the following disorders: a) CNS infection, with CSF evidence of meningitis, encephalitis, or other infectious process; b) Post-traumatic dementia, defined as dementia with a clear temporal relationship to a severe head injury where consciousness was lost; c) Huntington's disease; d) Multiple sclerosis; e) Parkinson's disease; f) Other neurologic disorders with focal signs, e.g., amyotrophic lateral sclerosis; g) Mental retardation. - Contra-indication to MRI scan: pacemaker, metal implants following surgery, any other contraindication to MRI (e.g., ferromagnetic aneurysm clips, heart valves). For patients with possible claustrophobia, they can do the MRI with adjunct lorazepam 0.5 mg to reduce anxiety. Patients who cannot do the MRI scan will still be eligible for the clinical trial, i.e., MRI is optional. |
Country | Name | City | State |
---|---|---|---|
United States | Duke University | Durham | North Carolina |
United States | New York State Psychiatric Institute | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute | National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | WMS-III Visual Reproduction Subtest | Screen (Week 0), Week 16, Week 40, Week 64, Week 78 | ||
Other | Trails A and B | Parts A and B are composed of 25 circles. Patients are asked to scan the entire page and identify the next number or letter in a sequence. | Screen (Week 0), Week 16, Week 40, Week 64, Week 78 | |
Other | Stroop | Screen (Week 0), Week 16, Week 40, Week 64, Week 78 | ||
Other | WAIS-III Digit Symbol Subtest | Screen (Week 0), Week 16, Week 40, Week 64, Week 78 | ||
Other | WAIS-III Block Design Subtest | Screen (Week 0), Week 16, Week 40, Week 64, Week 78 | ||
Other | COWAT | Screen (Week 0), Week 16, Week 40, Week 64, Week 78 | ||
Other | Boston Naming | Screen (Week 0), Week 16, Week 40, Week 64, Week 78 | ||
Other | Apolipoprotein E Genotype | Using a standard protocol, DNA is amplified by the polymerase chase reaction (PCR). The genotypes are determined blind to subject status (patient or control) by the sizes of DNA fragments present. | Week 2 | |
Other | University of Pennsylvania Smell Identification Test (UPSIT) | The subject will "scratch and sniff" 40 common odorants embedded in microcapsules on a separate page. The subject will choose the answer from a 4-item multiple choice list. Scores will range from 0-40. | Screen (Week 0) | |
Other | MRI Scan | Images will be obtained using a GE Signa 3 Tesla whole body scanner. T1-weighted sagittal fspgr and T2 FLAIR are the pulse sequences used in order to obtain the MRI images. | Within 1 month of Screen Visit (Week 0) | |
Other | WMS-R Logical Memory | Week 0 Screening | ||
Other | FC-SRT | Week 0 Screening | ||
Primary | Selective Reminding Test (SRT) Total Recall | The 12-item, 6-trial SRT is a memory measure used to assess verbal list learning and memory. The total number of words learned over six trials (total immediate recall) was obtained. | Week 16 | |
Primary | Selective Reminding Test (SRT) Delayed Recall | The 12-item, 6-trial SRT is a memory measure used to assess verbal list learning and memory. The total number of words learned over six trials (total immediate recall) and delayed recall (after a 15-minute delay) was obtained. | Week 16 | |
Secondary | Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) | The modified ADAS-Cog is a cognitive battery that assesses learning, memory, language production, language comprehension, constructional praxis, ideational praxis, and orientation. Subjects' scores represent the total number of errors made throughout the various tasks. The total number of possible errors is between 0-85. | Week 16 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A |