DepressionNCT00071643
Preventing Post-Stroke Depression
A study testing Problem Solving Therapy and Escitalopram in people with Depression and Cerebrovascular Accident, run by Robert G. Robinson at 3 sites in United States.
Trial summary
This study will evaluate the effectiveness of both drug and non-drug treatments in preventing depression after a stroke. Read more about this study
- Who is it for?
- Ages 31 to 89 years
- Conditions the study is for
- Depression, Cerebrovascular Accident
- What is being tested?
- Problem Solving Therapy and Escitalopram
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2002to Nov 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke within the last 120 days
Who cannot join
- DSM (Diagnostic and Statistical Manual) IV criteria for major or minor depressive disorder
- Heart, respiratory, kidney, or liver failure; severely disabling musculoskeletal disorder; or cancer
- Diagnosis of neurodegenerative disorders such as Parkinson's disease, Alzheimer's disease, Multiple System Atrophy, or Huntington's disease
- Pre-existing dementia or aphasia with severe language comprehension deficits
- Alcohol or substance abuse or dependence within the last 12 months
- Recurrent unipolar or bipolar disorder prior to the stroke
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Chicago
Chicago, Illinois, 60637
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242-1000
Burke Rehabilitation Hospital
White Plains, New York, 10605
About this study
Official title: Prevention of Post-Stroke Depression - Treatment Strategy
This study will evaluate the effectiveness of both drug and non-drug treatments in preventing depression after a stroke.
Read the detailed description
The development of depression after a stroke is a serious condition that can have negative effects on thought, emotions, and overall daily functioning, particularly in the first year following the stroke. Evidence suggests that antidepressants may be used to prevent post-stroke depression. This study will treat nondepressed stroke patients with antidepressants or problem solving therapy (PST) to determine the most effective treatments for preventing depression.
Participants in this study will be randomly assigned to receive PST, escitalopram, or placebo (an inactive pill) for 12 months. Participants who display depressive symptoms for 2 weeks or more will be removed from the study. After 12 months, treatment will be discontinued and participants will be monitored for an additional 6 months.
- Conditions
- Depression, Cerebrovascular Accident
- Being tested
- Problem Solving Therapy, Escitalopram, Placebo
- Keywords
- Stroke
- Medical subject headings
- Depression, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Solving TherapyBehavioural
Problem solving therapy aims to make patients aware of symptoms of problems and link those with behaviors associated with solving them.
EscitalopramDrug
Also called Lexapro
Participants will receive escitalopram, a selective serotonin reuptake inhibitor.
PlaceboOther
Participants will receive a placebo pill.
| Study group | Role | What they receive |
|---|---|---|
| 1 Problem Solving Therapy | Experimental | Participants will receive problem solving therapy. Receives: Behavioral: Problem Solving Therapy |
| 2. Escitalopram | Experimental | Participants will receive escitalopram. Receives: Drug: Escitalopram |
| 3 Placebo | Placebo comparator | Participants will receive placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of depressive disorders in the study population
Measured: Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18
Secondary outcomes (3)
Functional Independence Measure
Measured: Measured at baseline, at Week 6, and at Months 3, 6, 9, 12, and 18
Stroke Impact Scale
Measured: Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18
Neurocognitive tests of executive functions and speed of information processing
Measured: Measured at baseline and after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2003 (estimated)
- Study startSep 2002
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert G. Robinson
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Robert G. Robinson, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071643
- Sponsor's protocol ID
- 200207091
- Other IDs
- R01MH065134, DATR A4-GPX
- Status last verified
- Aug 2017
- First submitted
- 29 Oct 2003
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mikami K, Jorge RE, Moser DJ, Arndt S, Jang M, Solodkin A, Small SL, Fonzetti P, Hegel MT, Robinson RG. Increased frequency of first-episode poststroke depression after discontinuation of escitalopram. Stroke. 2011 Nov;42(11):3281-3. doi: 10.1161/STROKEAHA.111.626507. Epub 2011 Aug 25.
PubMed 21868736Jorge RE, Acion L, Moser D, Adams HP Jr, Robinson RG. Escitalopram and enhancement of cognitive recovery following stroke. Arch Gen Psychiatry. 2010 Feb;67(2):187-96. doi: 10.1001/archgenpsychiatry.2009.185.
PubMed 20124118Robinson RG, Jorge RE, Moser DJ, Acion L, Solodkin A, Small SL, Fonzetti P, Hegel M, Arndt S. Escitalopram and problem-solving therapy for prevention of poststroke depression: a randomized controlled trial. JAMA. 2008 May 28;299(20):2391-400. doi: 10.1001/jama.299.20.2391.
PubMed 18505948
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Post-Stroke Depression - Treatment Strategy
- ClinicalTrials.gov ID
- NCT00071643
- Acronym / sponsor ID
- 200207091
- Conditions
- Depression, Cerebrovascular Accident
- Keywords
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Robert G. RobinsonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2002
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 30 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effectiveness of both drug and non-drug treatments in preventing depression after a stroke.
Detailed description
The development of depression after a stroke is a serious condition that can have negative effects on thought, emotions, and overall daily functioning, particularly in the first year following the stroke. Evidence suggests that antidepressants may be used to prevent post-stroke depression. This study will treat nondepressed stroke patients with antidepressants or problem solving therapy (PST) to determine the most effective treatments for preventing depression.
Participants in this study will be randomly assigned to receive PST, escitalopram, or placebo (an inactive pill) for 12 months. Participants who display depressive symptoms for 2 weeks or more will be removed from the study. After 12 months, treatment will be discontinued and participants will be monitored for an additional 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 Problem Solving Therapy | Experimental | Behavioral: Problem Solving TherapyParticipants will receive problem solving therapy. |
| 2. Escitalopram | Experimental | Drug: EscitalopramParticipants will receive escitalopram. |
| 3 Placebo | Placebo comparator | Other: PlaceboParticipants will receive placebo. |
Who may qualify
- Ages
- 31 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stroke within the last 120 days
Key exclusion criteria (6 listed)
- DSM (Diagnostic and Statistical Manual) IV criteria for major or minor depressive disorder
- Heart, respiratory, kidney, or liver failure; severely disabling musculoskeletal disorder; or cancer
- Diagnosis of neurodegenerative disorders such as Parkinson's disease, Alzheimer's disease, Multiple System Atrophy, or Huntington's disease
- Pre-existing dementia or aphasia with severe language comprehension deficits
- Alcohol or substance abuse or dependence within the last 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Problem Solving TherapyProblem solving therapy aims to make patients aware of symptoms of problems and link those with behaviors associated with solving them. | Behavioural | 1 Problem Solving Therapy |
| EscitalopramAlso: LexaproParticipants will receive escitalopram, a selective serotonin reuptake inhibitor. | Drug | 2. Escitalopram |
| PlaceboParticipants will receive a placebo pill. | Other | 3 Placebo |
Primary outcome
Incidence of depressive disorders in the study population
Time frame: Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18
3 secondary outcomes
Functional Independence Measure
Time frame: Measured at baseline, at Week 6, and at Months 3, 6, 9, 12, and 18
Stroke Impact Scale
Time frame: Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18
Neurocognitive tests of executive functions and speed of information processing
Time frame: Measured at baseline and after 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
- Derived from this study: PubMed 21868736Mikami K, Jorge RE, Moser DJ, Arndt S, Jang M, Solodkin A, Small SL, Fonzetti P, Hegel MT, Robinson RG. Increased frequency of first-episode poststroke depression after discontinuation of escitalopram. Stroke. 2011 Nov;42(11):3281-3. doi: 10.1161/STROKEAHA.111.626507. Epub 2011 Aug 25.
- Derived from this study: PubMed 20124118Jorge RE, Acion L, Moser D, Adams HP Jr, Robinson RG. Escitalopram and enhancement of cognitive recovery following stroke. Arch Gen Psychiatry. 2010 Feb;67(2):187-96. doi: 10.1001/archgenpsychiatry.2009.185.
- Derived from this study: PubMed 18505948Robinson RG, Jorge RE, Moser DJ, Acion L, Solodkin A, Small SL, Fonzetti P, Hegel M, Arndt S. Escitalopram and problem-solving therapy for prevention of poststroke depression: a randomized controlled trial. JAMA. 2008 May 28;299(20):2391-400. doi: 10.1001/jama.299.20.2391.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem Solving Therapy and Escitalopram in people with Depression and Cerebrovascular Accident, run by Robert G. Robinson at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of depressive disorders in the study population (time frame: Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00071643, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.