| Conditions: |
|
Depression |
| Purpose: |
|
This study will examine whether combined use of an antidepressant medication and the
medication nimodipine reduces risk of depression relapse in patients with vascular
depression.
|
| Study Summary: |
|
Depressed elderly patients often show signs of cerebrovascular disease, commonly known as a
stroke. Some scientists theorize that having cerebrovascular disease may affect depression
in older adults in one of three ways: by causing depression, by making it more likely that
people who have been depressed have a relapse, or by maintaining certain depressive symptoms
in those already depressed. The combination of depression and cerebrovascular disease in
older adults is referred to as vascular depression and is associated with psychomotor
slowing, functional impairment, and cognitive impairment. Additionally, the likelihood of
improvement or remission is lower in vascular depression and is more difficult to treat over
time.
Nimodipine (NIM) is FDA approved to reduce incidence and severity of problems with blood
flow resulting from a particular type of stroke. In addition to improving blood flow in the
brain following a stroke, NIM also protects neurons from injury or degeneration and has
cognitive and functional benefits. These positive effects of NIM may make it useful for
treatment of vascular depression. In a previous study of people with vascular depression,
pairing NIM with the antidepressant fluoxetine showed greater improvements in depression
treatment outcomes, higher likelihood of full remission, and less incidence of depression
recurrence than using fluoxetine alone. This study will examine whether pairing NIM with
other antidepressants will reduce recurrence of vascular depression.
Participation in this study will last 56 weeks and will be divided into two phases. Before
the first phase, participants will undergo a 2-hour psychiatric evaluation and a 1.5-hour
medical examination that will involve a physical examination, blood test, electrocardiogram
(EKG), and urine analysis. In the first phase, participants will receive antidepressant
medication without NIM. Participants will begin taking escitalopram but may be switched to
duloxetine or have lorazepam added to their regimen, depending on individual treatment
effectiveness and side effects. The first phase will last between 6 and 24 weeks, ending
when the individual participant either responds to medication or experiences 24 weeks of
nonresponse. During the first phase, participants will attend weekly study visits, during
which researchers will assess medication effectiveness and monitor side effects.
Before the second phase, participants will undergo a half-hour medical examination and a
1.5-hour test of cognitive and physical abilities. At the beginning of the second phase,
participants will be randomly assigned to receive either NIM or a placebo in addition to
continuing with the antidepressant medication already helping them. Participants will take
NIM or the placebo for 8 months, undergoing weekly study visits for the first month and
monthly study visits for the last 7 months. During these visits, researchers will monitor
the participants' health and reactions to their medications. After 4, 16, and 32 weeks, an
EKG test will be performed, and after 16 and 32 weeks, cognitive and physical tests will be
performed again. After the 8 months, participants will attend three weekly study visits
while their use of medication is lowered and then ended.
For information on a related study, please follow this link:
http://clinicaltrials.gov/show/NCT00177424
|
| Criteria: |
|
Inclusion Criteria:
- Current DSM-IV diagnosis of major depression
- Score greater than 15 on the 24-item Hamilton Depression Rating Scale (HDRS24)
- Significant cerebrovascular disease risk factors, as defined by the presence of more
than three of the following:
1. Arterial hypertension, defined by a systolic blood pressure higher than 140 mm
Hg or a diastolic blood pressure higher than 90 mm Hg, or by both a
self-reported hypertension diagnosis and use of antihypertensive medication
2. Diabetes mellitus, defined by a fasting blood glucose level higher than 126
mg/dl or treatment with hypoglycemic agents or insulin in the year before study
entry
3. Obesity, defined by a current body mass index (BMI) greater than 30
4. Hyperlipidemia, defined by either a confirmed prior diagnosis or a current
fasting cholesterol level higher than 200 mg/dl
5. Current smoker
- Able to swallow oral medication
- Identification of a family member or friend willing and able to participate as a
source of corroborating information
- Able to speak English
- A hearing capacity adequate to respond to a raised conversational voice
Exclusion Criteria:
- Current diagnosis of major depression with psychosis, schizophrenia, bipolar
disorder, schizophreniform disorder, schizoaffective disorder, schizotypal disorder,
or obsessive compulsive disorder
- Meets DSM-IV criteria for dementia or has a score of 17 or lower on the Mini Mental
State Examination
- Met DSM-IV criteria for drug or alcohol dependence within the past 6 months
- Not responsive to therapeutic trials of either escitalopram or duloxetine for the
current major depressive episode
- Acute, severe, or unstable medical disorder likely to interfere with treatment, such
as untreated thyroid disorder
- History of epilepsy
- Clinically reported stroke within the past year
- First-degree heart block, determined after correcting for age
- Symptomatic hypotension or symptomatic orthostatic hypotension
- History of nontolerance or allergy to both escitalopram and duloxetine therapy,
including history of selective serotonin reuptake inhibitor (SSRI)-related syndrome
of inappropriate anti-diuretic hormone secretion (SIADH)
- Significant allergy to NIM or other ingredients contained in the study medication
- Taken monoamine oxidase inhibitors (MAOIs) within the 2 weeks prior to the first
administration of double-blind study medication
- Requires treatment with amiodarone, protease inhibitors, dalfopristin or
quinupristin, valproic acid, triazole antifungal agents (e.g., itraconazole),
reserpine, methyldopa, guanethidine, or clonidine during the course of the study
- May require drugs known to interact with NIM during the course of the study
- Refusal to allow the research team to contact participant's primary medical provider
- Planning to become pregnant during the course of the study
|
| NCT ID: |
|
NCT00781326 |
| Primary Contact: |
|
Principal Investigator
Ellen M. Whyte, MD
University of Pittsburgh
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Pittsburgh, Pennsylvania 15213
United States
Nancy McLaughlin, BSN
Phone: 412-246-6008
Email: mclaughlinn@upmc.edu
Site Status: Recruiting |