Major Depressive DisorderPhase 4PRISMSNCT00592384
Project to Improve Symptoms and Mood in People With Spinal Cord Injury
A Phase 4 study testing venlafaxine XR in people with Major Depressive Disorder and Dysthymia, run by University of Washington at 6 sites in United States.
Trial summary
Depression is likely the most prevalent and disabling psychological complication associated with spinal cord injury (SCI). Yet no controlled depression treatment trials have been performed in this population. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Major Depressive Disorder, Dysthymia, Spinal Cord Injuries
- What is being tested?
- venlafaxine XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2007to Sep 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Spinal cord injury (ASIA A-D)
- At least one month post injury
- Meets DSM IV criteria for major depression or dysthymia on the SCID
- At least moderately severe depression (PHQ-9 score >= 10)
- Within reasonable travel distance to one of the study sites
Who cannot join
- Current DSM IV alcohol or drug dependence
- History of bipolar disorder or psychosis
- History of >= 2 suicide attempts or suicide attempt with 5 years
- Current suicidal intent or plan
- Medical contraindications
- Non-English speaker
Show all 16Show fewer
- Clinically significant cognitive/language impairment
- History of allergic reaction to venlafaxine XR or use of MAO-I with 2 weeks
- Current use of antidepressant medications (will not exclude if on low dose of a tricyclic antidepressant or trazodone for pain, sleep, or bladder), psychotherapy for depression, or electroconvulsive therapy
- Pregnant or lactating women or women of childbearing potential who are not willing to use a reliable form of contraception
- Unstable medical condition, as determined by physical examination, CBC w/ platelets (including hematocrit, hemoglobin, WBC, differential), serum chemistry panel (serum sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose), liver transaminases (AST, ALT), thyroid stimulating hormone (TSH), urinalysis, supine diastolic blood pressure (SDBP) > 90 mm Hg, or near terminal illness (primary care physician estimates that patient has < 1 year to live)
- Anticipated major surgical procedures within the 12 weeks of randomization
- Use of an investigational drug within 30 days
- Use of psychoactive medications, including corticosteroids and anticonvulsants, that have not been at a stable dose for at least 2 weeks
- Use of anxiolytic, sedative-hypnotic, or other psychotropic drug or substance (including St. John's Wort) within 7 days of start of double-blind treatment. If the patient is taking a sedative deemed necessary for sleep induction or spasticity, the dosage must have been stable for at least 2 weeks. Use of anticholinergic, low-dose tricyclic antidepressant, GABAergic or adrenergic medications for spasticity are permitted if at a stable dose for at least 2 weeks.
- Refusal to participate
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan
Ann Arbor, Michigan, 48109-0491
University of Alabama
Birmingham, Alabama, 35294-0111
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611-2654
Baylor Institute for Rehabilitation
Dallas, Texas, 75246
University of Miami
Miami, Florida, 33124
University of Washington/Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: A Controlled Trial of Venlafaxine XR for Major Depression After Spinal Cord Injury: A Multi-site Study
Depression is likely the most prevalent and disabling psychological complication associated with spinal cord injury (SCI). Yet no controlled depression treatment trials have been performed in this population. The proposed study is a multi-site, randomized, double-blind, placebo controlled trial of venlafaxine XR (Effexor XR) in 133 adults with SCI and major depressive disorder (MDD) or dysthymia who are at least one month post injury. Participants will be recruited from four SCI Model System sites, the University of Washington, Rehabilitation Institute of Chicago, University of Michigan, University of Alabama, Birmingham and Baylor Institute for Rehabilitation, Dallas, TX. The purpose of the study is to examine the efficacy and tolerability of venlafaxine XR as a treatment for MDD. The primary outcome will be the percent of responders (those who report at least a 50% reduction in depression severity from baseline to the end of treatment) in the venlafaxine XR versus placebo control group using intent-to-treat analysis. Secondary outcomes will include changes in pain, health related quality of life depression-related disability and community participation. A successful clinical trial could lead to more aggressive identification and treatment of MDD as well as improved health and quality of life in this important population.
Read the detailed description
Depression is likely the most prevalent and disabling psychological complication associated with spinal cord injury (SCI). The prevalence of major depression in people with SCI is 22% or two to six times higher than in the general population. Depression is linked to a myriad of adverse outcomes including poor subjective health, poor community integration, higher rates of medical complications and high rates of suicide. Surprisingly there are no randomized controlled trials for treating major depressive disorder (MMD) in people with SCI. Despite the widespread use of antidepressants in this population, the common assumption that antidepressant medications are effective and well-tolerated among people with SCI is uncertain. Multiple factors such as severe stresses, bereavement and loss of rewarding activities may complicate treatment. Treatment trials suggest antidepressants may not be as effective in people with medical/neurological conditions as they are with depression that develops as a primary condition. For almost 20 years clinicians and scientists have called for controlled clinical trials of antidepressants among people with SCI in order to establish evidence-based treatment. The proposed study is a multi-site, randomized, double-blind, placebo controlled trial of venlafaxine XR (Effexor XR) in 133 adults with SCI and MDD or dysthymia who are at least one month post injury. Participants aged 18-64 will be recruited from four SCI Model System sites, the University of Washington, Rehabilitation Institute of Chicago, University of Michigan, University of Alabama, Birmingham and Baylor Institute for Rehabilitation, Dallas TX. The purpose of the study is to examine the efficacy and tolerability of venlafaxine XR as a treatment for MDD. The primary outcome will be the percent of responders (those who report at least a 50% reduction in depression severity from baseline to the end of treatment) in the venlafaxine XR versus placebo control group using intent-to-treat analysis. Secondary outcomes will include changes in pain, health related quality of life and participation. A successful clinical trial could lead to more aggressive identification and treatment of MDD as well as improved health and quality of life in this important population.
- Conditions
- Major Depressive Disorder, Dysthymia, Spinal Cord Injuries
- Being tested
- venlafaxine XR, placebo
- Keywords
- spinal cord injuries, major depressive disorder, dysthymia, antidepressant agents, pain, quality of life, muscle spasticity, community participation, anxiety
- Medical subject headings
- Depressive Disorder, Major, Dysthymic Disorder, Spinal Cord Injuries, Pain, Muscle Spasticity, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venlafaxine XRDrug
Also called Effexor XR
Once daily oral dose of venlafaxine XR ranging from 37.5 mg up to 300 mg
placeboDrug
Also called identically encapsulated inactive substance
Once daily oral dose of placebo ranging from 37.5 mg up to 300 mg
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | identically encapsulated placebo pills 37.5 - 300 mg/day for 12 weeks Receives: Drug: placebo |
| venlafaxine XR | Experimental | venlafaxine XR 37.5 - 300 mg/day for 12 weeks Receives: Drug: venlafaxine XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale-17
The 17-item Hamilton Depression Rating Scale is a clinician rated measure of depression severity (we used a structured interview version (Williams 1988) to improve inter-rater reliability). Scores range from 0-52. Higher scores indicate more severe depression. Scores of 7 or less indicate remission from depression.
Measured: 0 weeks, 12 weeks
Hamilton Depression Rating Scale-Maier Subscale
The Maier is a 6-item sub scale of the Hamilton derived from Rasch analysis. It is a unidimensional scale with superior sensitivity to change. It excludes somatic items and is therefore especially appropriate for individuals who have substantial physical impairment and medical comorbidity. Scores can range from 0-22 with higher scores indicating more severe depression. Scores of 4 or less indicated in remission from depression.
Measured: 0 weeks, 12 weeks
Secondary outcomes (12)
Symptom Checklist-20 Depression Subscale
Measured: Weeks 0, 1, 3, 6, 8, 10, 12, 24
Modified Brief Pain Inventory
Measured: Weeks 0, 1, 3, 6, 8, 10, 12
Modified Ashworth Spasticity Scale
Measured: Weeks 0, 1, 3, 6, 8, 10, 12
Structured Clinical Interview for DSM IV Depression Module
Measured: Weeks 0, 12, 24
SF-12
Measured: Weeks 0, 12, 24
Side Effects Checklist
Measured: Weeks 0, 1, 3, 6, 8, 10, 12
Craig Handicap and Reporting Technique
Measured: Weeks 0, 12
Satisfaction With Life
Measured: Weeks 0, 12
Sheehan Disability Scale
Measured: Weeks 0, 12
Clinical Global Impression
Measured: Weeks 0, 1, 3, 6, 8, 10, 12
Patient Global Impression
Measured: Weeks 0, 1, 3, 6, 8, 10, 12
Hamilton Rating Scale for Anxiety
Measured: Weeks 0, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startJul 2007
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Shirley Ryan AbilityLab, University of Alabama at Birmingham, Baylor Health Care System, University of Miami, New York University
- Responsible party
- Principal investigator, Charles Bombardier, University of Washington
- Investigators
- Charles H. Bombardier, PhD, Principal investigator, University of Washington School of Medicine, Department of Rehabilitation MedicineJesse R. Fann, MD, MPH, Principal investigator, University of Washington School of Medicine, Department of Psychiatry and Behavioral Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592384
- Sponsor's protocol ID
- 31665-D
- Other IDs
- H133A060107;
- Acronym
- PRISMS
- Status last verified
- Dec 2014
- First submitted
- 1 Jan 2008
- Last updated
- 1 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
McCullumsmith CB, Kalpakjian CZ, Richards JS, Forchheimer M, Heinemann AW, Richardson EJ, Wilson CS, Barber J, Temkin N, Bombardier CH, Fann JR; PRISMS Investigators. Novel risk factors associated with current suicidal ideation and lifetime suicide attempts in individuals with spinal cord injury. Arch Phys Med Rehabil. 2015 May;96(5):799-808. doi: 10.1016/j.apmr.2014.12.017. Epub 2015 Jan 19.
PubMed 25613597Fann JR, Bombardier CH, Richards JS, Wilson CS, Heinemann AW, Warren AM, Brooks L, McCullumsmith CB, Temkin NR, Warms C, Tate DG; PRISMS Investigators. Venlafaxine extended-release for depression following spinal cord injury: a randomized clinical trial. JAMA Psychiatry. 2015 Mar;72(3):247-58. doi: 10.1001/jamapsychiatry.2014.2482.
PubMed 25607727Bombardier CH, Fann JR, Tate DG, Richards JS, Wilson CS, Warren AM, Temkin NR, Heinemann AW; PRISMS Investigators. An exploration of modifiable risk factors for depression after spinal cord injury: which factors should we target? Arch Phys Med Rehabil. 2012 May;93(5):775-81. doi: 10.1016/j.apmr.2011.12.020. Epub 2012 Mar 20.
PubMed 22440484Fann JR, Bombardier CH, Richards JS, Tate DG, Wilson CS, Temkin N; PRISMS Investigators. Depression after spinal cord injury: comorbidities, mental health service use, and adequacy of treatment. Arch Phys Med Rehabil. 2011 Mar;92(3):352-60. doi: 10.1016/j.apmr.2010.05.016. Epub 2011 Jan 20.
PubMed 21255766
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Trial of Venlafaxine XR for Major Depression After Spinal Cord Injury: A Multi-site Study
- ClinicalTrials.gov ID
- NCT00592384
- Acronym / sponsor ID
- PRISMS / 31665-D
- Conditions
- Major Depressive Disorder, Dysthymia, Spinal Cord Injuries
- Keywords
- spinal cord injuries, major depressive disorder, dysthymia, antidepressant agents, pain, quality of life, muscle spasticity, community participation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- University of Michigan, Shirley Ryan AbilityLab, University of Alabama at Birmingham, Baylor Health Care System, University of Miami, New York University
- Study start
- Jul 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 14 Jan 2008 (estimated)
- Results
- Posted 1 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Depression is likely the most prevalent and disabling psychological complication associated with spinal cord injury (SCI). Yet no controlled depression treatment trials have been performed in this population. The proposed study is a multi-site, randomized, double-blind, placebo controlled trial of venlafaxine XR (Effexor XR) in 133 adults with SCI and major depressive disorder (MDD) or dysthymia who are at least one month post injury. Participants will be recruited from four SCI Model System sites, the University of Washington, Rehabilitation Institute of Chicago, University of Michigan, University of Alabama, Birmingham and Baylor Institute for Rehabilitation, Dallas, TX. The purpose of the study is to examine the efficacy and tolerability of venlafaxine XR as a treatment for MDD. The primary outcome will be the percent of responders (those who report at least a 50% reduction in depression severity from baseline to the end of treatment) in the venlafaxine XR versus placebo control group using intent-to-treat analysis. Secondary outcomes will include changes in pain, health related quality of life depression-related disability and community participation. A successful clinical trial could lead to more aggressive identification and treatment of MDD as well as improved health and quality of life in this important population.
Detailed description
Depression is likely the most prevalent and disabling psychological complication associated with spinal cord injury (SCI). The prevalence of major depression in people with SCI is 22% or two to six times higher than in the general population. Depression is linked to a myriad of adverse outcomes including poor subjective health, poor community integration, higher rates of medical complications and high rates of suicide. Surprisingly there are no randomized controlled trials for treating major depressive disorder (MMD) in people with SCI. Despite the widespread use of antidepressants in this population, the common assumption that antidepressant medications are effective and well-tolerated among people with SCI is uncertain. Multiple factors such as severe stresses, bereavement and loss of rewarding activities may complicate treatment. Treatment trials suggest antidepressants may not be as effective in people with medical/neurological conditions as they are with depression that develops as a primary condition. For almost 20 years clinicians and scientists have called for controlled clinical trials of antidepressants among people with SCI in order to establish evidence-based treatment. The proposed study is a multi-site, randomized, double-blind, placebo controlled trial of venlafaxine XR (Effexor XR) in 133 adults with SCI and MDD or dysthymia who are at least one month post injury. Participants aged 18-64 will be recruited from four SCI Model System sites, the University of Washington, Rehabilitation Institute of Chicago, University of Michigan, University of Alabama, Birmingham and Baylor Institute for Rehabilitation, Dallas TX. The purpose of the study is to examine the efficacy and tolerability of venlafaxine XR as a treatment for MDD. The primary outcome will be the percent of responders (those who report at least a 50% reduction in depression severity from baseline to the end of treatment) in the venlafaxine XR versus placebo control group using intent-to-treat analysis. Secondary outcomes will include changes in pain, health related quality of life and participation. A successful clinical trial could lead to more aggressive identification and treatment of MDD as well as improved health and quality of life in this important population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placeboidentically encapsulated placebo pills 37.5 - 300 mg/day for 12 weeks |
| venlafaxine XR | Experimental | Drug: venlafaxine XRvenlafaxine XR 37.5 - 300 mg/day for 12 weeks |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Spinal cord injury (ASIA A-D)
- At least one month post injury
- Meets DSM IV criteria for major depression or dysthymia on the SCID
- At least moderately severe depression (PHQ-9 score >= 10)
- Within reasonable travel distance to one of the study sites
Key exclusion criteria (16 listed)
- Current DSM IV alcohol or drug dependence
- History of bipolar disorder or psychosis
- History of >= 2 suicide attempts or suicide attempt with 5 years
- Current suicidal intent or plan
- Medical contraindications
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 |
|---|---|---|
| venlafaxine XRAlso: Effexor XROnce daily oral dose of venlafaxine XR ranging from 37.5 mg up to 300 mg | Drug | venlafaxine XR |
| placeboAlso: identically encapsulated inactive substanceOnce daily oral dose of placebo ranging from 37.5 mg up to 300 mg | Drug | placebo |
Primary outcome
Hamilton Depression Rating Scale-17
Time frame: 0 weeks, 12 weeks
The 17-item Hamilton Depression Rating Scale is a clinician rated measure of depression severity (we used a structured interview version (Williams 1988) to improve inter-rater reliability). Scores range from 0-52. Higher scores indicate more severe depression. Scores of 7 or less indicate remission from depression.
Hamilton Depression Rating Scale-Maier Subscale
Time frame: 0 weeks, 12 weeks
The Maier is a 6-item sub scale of the Hamilton derived from Rasch analysis. It is a unidimensional scale with superior sensitivity to change. It excludes somatic items and is therefore especially appropriate for individuals who have substantial physical impairment and medical comorbidity. Scores can range from 0-22 with higher scores indicating more severe depression. Scores of 4 or less indicated in remission from depression.
12 secondary outcomes
Symptom Checklist-20 Depression Subscale
Time frame: Weeks 0, 1, 3, 6, 8, 10, 12, 24
Modified Brief Pain Inventory
Time frame: Weeks 0, 1, 3, 6, 8, 10, 12
Modified Ashworth Spasticity Scale
Time frame: Weeks 0, 1, 3, 6, 8, 10, 12
Structured Clinical Interview for DSM IV Depression Module
Time frame: Weeks 0, 12, 24
SF-12
Time frame: Weeks 0, 12, 24
Side Effects Checklist
Time frame: Weeks 0, 1, 3, 6, 8, 10, 12
Craig Handicap and Reporting Technique
Time frame: Weeks 0, 12
Satisfaction With Life
Time frame: Weeks 0, 12
Sheehan Disability Scale
Time frame: Weeks 0, 12
Clinical Global Impression
Time frame: Weeks 0, 1, 3, 6, 8, 10, 12
Patient Global Impression
Time frame: Weeks 0, 1, 3, 6, 8, 10, 12
Hamilton Rating Scale for Anxiety
Time frame: Weeks 0, 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25613597McCullumsmith CB, Kalpakjian CZ, Richards JS, Forchheimer M, Heinemann AW, Richardson EJ, Wilson CS, Barber J, Temkin N, Bombardier CH, Fann JR; PRISMS Investigators. Novel risk factors associated with current suicidal ideation and lifetime suicide attempts in individuals with spinal cord injury. Arch Phys Med Rehabil. 2015 May;96(5):799-808. doi: 10.1016/j.apmr.2014.12.017. Epub 2015 Jan 19.
- Derived from this study: PubMed 25607727Fann JR, Bombardier CH, Richards JS, Wilson CS, Heinemann AW, Warren AM, Brooks L, McCullumsmith CB, Temkin NR, Warms C, Tate DG; PRISMS Investigators. Venlafaxine extended-release for depression following spinal cord injury: a randomized clinical trial. JAMA Psychiatry. 2015 Mar;72(3):247-58. doi: 10.1001/jamapsychiatry.2014.2482.
- Derived from this study: PubMed 22440484Bombardier CH, Fann JR, Tate DG, Richards JS, Wilson CS, Warren AM, Temkin NR, Heinemann AW; PRISMS Investigators. An exploration of modifiable risk factors for depression after spinal cord injury: which factors should we target? Arch Phys Med Rehabil. 2012 May;93(5):775-81. doi: 10.1016/j.apmr.2011.12.020. Epub 2012 Mar 20.
- Derived from this study: PubMed 21255766Fann JR, Bombardier CH, Richards JS, Tate DG, Wilson CS, Temkin N; PRISMS Investigators. Depression after spinal cord injury: comorbidities, mental health service use, and adequacy of treatment. Arch Phys Med Rehabil. 2011 Mar;92(3):352-60. doi: 10.1016/j.apmr.2010.05.016. Epub 2011 Jan 20.
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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.
Charles H. Bombardier, PhD principal investigator
University of Washington School of Medicine, Department of Rehabilitation Medicine
Jesse R. Fann, MD, MPH principal investigator
University of Washington School of Medicine, Department of Psychiatry and Behavioral Science
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing venlafaxine XR in people with Major Depressive Disorder and Dysthymia, run by University of Washington at 6 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 5 inclusion and 16 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 1 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hamilton Depression Rating Scale-17 (time frame: 0 weeks, 12 weeks). The study lists 2 primary outcomes in all. 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 NCT00592384, which also lists 4 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 1 Jan 2015.