Major Depressive DisorderNCT00853346
Psychosocial Treatment of Depression in Parkinson's Disease
A study testing Cognitive Behavioral Therapy in people with Major Depressive Disorder and Parkinson's Disease, run by Amy Farabaugh, PhD at 1 site in United States.
Trial summary
The purpose of the study is to examine the effects of a form of talk therapy called cognitive behavior therapy (CBT) in the treatment of major depression in individuals with Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Major Depressive Disorder, Parkinson's Disease
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Apr 2013
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In addition to the DSM-IV diagnostic criteria for major depressive disorder, the following conditions must be met for patient eligibility:
- Written informed consent.
- Subjects with a primary diagnosis of PD who also currently meet DSM-IV criteria for MDD
- Subjects must be stable on their anti-Parkinson treatment, as defined by no medication changes over the past 6 weeks
- Subjects may be taking an antidepressant as long as they have had a stable dose for up to 6 weeks and do not alter the dosage during the course of the study
- Men or women 40-80 years of age
Show all 9Show fewer
- HAMD-17 scores > 14 at screen visit
- Score of 25 or greater on the Mini-Mental Status Examination
- Willing to come to MGH for screening and study participation
Who cannot join
- Patients meeting any of the following criteria are to be excluded from the study:
- Subjects who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk
- Patients who would not be appropriate for a delayed CBT control due to the severity of their depression based on clinical judgment as well as HAMD-17 scores > 28
- The following DSM-IV diagnoses: 1) substance use disorders, including alcohol dependence, active within the last 3 months; 2) schizophrenia; 3) delusional disorder; 4) psychotic disorders not elsewhere classified; 5) bipolar disorder; 6) MDD with psychotic features
- Subjects who meet DSM-IV criteria for dementia
- Severe, unstable concurrent medical conditions (determined by his/her physician) that are likely to require hospitalization within six months from study entry (e.g., a patient with severe congestive heart failure who has a history of recent hospital admissions)
- Subjects may not be receiving a psychosocial intervention that is specific for depression; psychosocial interventions not specific for depression (e.g., couples counseling) and established for three or more months before screen visit are allowed
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The purpose of the study is to examine the effects of a form of talk therapy called cognitive behavior therapy (CBT) in the treatment of major depression in individuals with Parkinson's disease (PD).
Read the detailed description
CBT is a specific type of treatment that has been shown to be as helpful in treating depression as medications for depression. CBT focuses on thoughts, feelings, and behaviors. It focuses on the here and now, rather than the past. CBT offers concrete strategies and skills for coping with depression, PD, and other life problems. Previous research leads us to believe that this type of therapy may help people with PD cope with their depression.
- Conditions
- Major Depressive Disorder, Parkinson's Disease
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- Depression, Parkinson's Disease, Major Depression, Cognitive Behavioral Therapy
- Medical subject headings
- Depressive Disorder, Major, Parkinson Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Also called CBT, Cognitive Therapy, Therapy, Psychosocial Intervention
12 weeks of Cognitive Behavioral Therapy designed for adults with Parkinson's Disease and comorbid Depression
Cognitive Behavioral TherapyBehavioural
Also called CBT, Cognitive Therapy, Therapy, Psychosocial Intervention
12 weeks of Cognitive Behavioral Therapy designed for adults with Parkinson's Disease and comorbid Depression
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients randomized to the immediate arm will be given 12 weeks of CBT starting one week after randomization Receives: Behavioral: Cognitive Behavioral Therapy |
| 2 | Active comparator | Patients in the delayed arm will receive 12 weeks of CBT, starting 12 weeks after randomization. Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response according to the Hamilton Rating Scale for Depression, 17 items (HAM-D 17).
Measured: screen, week 4, week 8, week 12; if applicable, week 16, week 20, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startApr 2007
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amy Farabaugh, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amy Farabaugh, PhD, Massachusetts General Hospital
- Investigators
- Amy Farabaugh, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853346
- Sponsor's protocol ID
- MH076037-01
- Status last verified
- Nov 2012
- First submitted
- 27 Feb 2009
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Treatment of Depression in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00853346
- Acronym / sponsor ID
- MH076037-01
- Conditions
- Major Depressive Disorder, Parkinson's Disease
- Keywords
- Depression, Parkinson's Disease, Major Depression, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Amy Farabaugh, PhDUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Beth Israel Deaconess Medical Center
- Study start
- Apr 2007
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 2 Mar 2009 (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.
The purpose of the study is to examine the effects of a form of talk therapy called cognitive behavior therapy (CBT) in the treatment of major depression in individuals with Parkinson's disease (PD).
Detailed description
CBT is a specific type of treatment that has been shown to be as helpful in treating depression as medications for depression. CBT focuses on thoughts, feelings, and behaviors. It focuses on the here and now, rather than the past. CBT offers concrete strategies and skills for coping with depression, PD, and other life problems. Previous research leads us to believe that this type of therapy may help people with PD cope with their depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Cognitive Behavioral TherapyPatients randomized to the immediate arm will be given 12 weeks of CBT starting one week after randomization |
| 2 | Active comparator | Behavioral: Cognitive Behavioral TherapyPatients in the delayed arm will receive 12 weeks of CBT, starting 12 weeks after randomization. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- In addition to the DSM-IV diagnostic criteria for major depressive disorder, the following conditions must be met for patient eligibility:
- Written informed consent.
- Subjects with a primary diagnosis of PD who also currently meet DSM-IV criteria for MDD
- Subjects must be stable on their anti-Parkinson treatment, as defined by no medication changes over the past 6 weeks
- Subjects may be taking an antidepressant as long as they have had a stable dose for up to 6 weeks and do not alter the dosage during the course of the study
Key exclusion criteria (7 listed)
- Subjects who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk
- Patients who would not be appropriate for a delayed CBT control due to the severity of their depression based on clinical judgment as well as HAMD-17 scores > 28
- The following DSM-IV diagnoses: 1) substance use disorders, including alcohol dependence, active within the last 3 months; 2) schizophrenia; 3) delusional disorder; 4) psychotic disorders not elsewhere classified; 5) bipolar disorder; 6) MDD with psychotic features
- Subjects who meet DSM-IV criteria for dementia
- Severe, unstable concurrent medical conditions (determined by his/her physician) that are likely to require hospitalization within six months from study entry (e.g., a patient with severe congestive heart failure who has a history of recent hospital admissions)
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 |
|---|---|---|
| Cognitive Behavioral TherapyAlso: CBT, Cognitive Therapy, Therapy, Psychosocial Intervention12 weeks of Cognitive Behavioral Therapy designed for adults with Parkinson's Disease and comorbid Depression | Behavioural | 1 |
| Cognitive Behavioral TherapyAlso: CBT, Cognitive Therapy, Therapy, Psychosocial Intervention12 weeks of Cognitive Behavioral Therapy designed for adults with Parkinson's Disease and comorbid Depression | Behavioural | 2 |
Primary outcome
Response according to the Hamilton Rating Scale for Depression, 17 items (HAM-D 17).
Time frame: screen, week 4, week 8, week 12; if applicable, week 16, week 20, week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2012.
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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.
Amy Farabaugh, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Major Depressive Disorder and Parkinson's Disease, run by Amy Farabaugh, PhD at 1 site 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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 16 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
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?
Response according to the Hamilton Rating Scale for Depression, 17 items (HAM-D 17). (time frame: screen, week 4, week 8, week 12; if applicable, week 16, week 20, week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2012.