Low Back PainPhase 4NCT00227292
Cipralex in Treatment of Depressive Symptoms and Chronic Back Pain
A Phase 4 study testing Escitalopram in people with Low Back Pain and Depression, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial summary
Chronic low back pain (CLBP) is one of the most frequent forms of chronic pain and can result in significant functional impairment. This is often associated with major depression too. Previous research reported significant beneficial effects of antidepressant medication in alleviating depression and pain intensity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Depression
- What is being tested?
- Escitalopram
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2007to Nov 2012
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In- and out-patients at KH Bethanien, Greifswald, presenting with non-specific chronic low back pain lasting longer than 6 months (assessed with VAS and OLBPQ rev.)
- Age from 18 to 65 years
- Depressive symptoms (HAMD scores >10)
- Significant disability in daily living tasks (Owestry Disability Index >30%)
- Medication with nonsteroidal anti-inflammatory drugs.
Who cannot join
- Other significant Axis I disorders, including psychosis, eating disorders, substance use disorders or recent suicidal behavior.
- Systemic inflammatory disorder, malignancy, other acute medical or neurological disorders, recent surgery within 12 months.
- Medication with opioids, corticosteroids, other psychotropic medication except Temazepam.
- History of gastric ulcer, gastritis or gastric bleeding.
- Known allergy or intolerance to Citalopram or Cipralex.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Chronic low back pain (CLBP) is one of the most frequent forms of chronic pain and can result in significant functional impairment. This is often associated with major depression too. Previous research reported significant beneficial effects of antidepressant medication in alleviating depression and pain intensity. The aim of this study is to evaluate the efficacy of Escitalopram, a new kind of Selective Serotonin Reuptake Inhibitor (SSRI) in patients with CLBP in a prospective, randomized and double-blind clinical trial. The main hypothesis is:
-in comparison to placebo, subjects with CLBP and Cipralex report a significant reduction in depressive symptoms (>= 50% of HAMD questionnaire) after 4 weeks of treatment.
Read the detailed description
Pain is an unpleasant sensory and emotional experience. Chronic pain, including chronic low back pain, represents a major public health problem. Risk factors of chronicity of low back pain include high levels of psychological distress prior to or during the episode, premorbid association with work status or employment dissatisfaction, unemployment, poor self-rated health and low levels of physical activity. Other psychosocial features are poor social and educational status, previous sexual or physical abuse. Furthermore, mechanical strain on the spine from heavy lifting, repetitive lifting, twisting and vibration, including driving increase the risk. Static work postures, prolonged standing or walking, road traffic accidents and falls are also significantly related.While there is little evidence for a specific personality profile, stress, distress, anxiety, mood disorders and depression were consistently related to neck and back pain.
CLBP is associated with significant disability, functional impairment, high rates of psychiatric symptoms including anxiety and depression, and loss of other physical roles. These may produce social and functional problems, which include reduced earning capacity, unemployment and family disharmony. Chronic pain is also associated with loss of self confidence and self-esteem, leading to social withdrawal and social isolation. Men with CLBP have significantly higher lifetime rates of major depression, alcohol use disorder and major anxiety disorder. After age of pain onset, CLBP subjects had over 9 times the risk of developing major depression.
Depression is believed to be mediated by 5-HT and norepinephrine through the raphe nucleus and locus coeruleus projections to the cerebral cortex and forebrain limbic systems, whereas pain is believed to be mediated in part through descending 5-HT and norepinephrine pain pathways that provide inhibitory input to the dorsal horn neurons in the spinal cord. Global deficiences in 5-HT or norepinephrine neurotransmission would be predicted to affect both mood and pain thresholds, possibly accounting for the hgh comorbidity of painful symptoms in patients with depression.Accordingly, enhancement of both neurotransmitter or 5-HT alone would be expected both to improve symptoms of depression and to normalize pain thresholds.
In antidepressant treatment of CLBP, only 2 studies were published using SSRIs. One reported significantly higher pain intensity reduction in maprotilin group compared to paroxetine and placebo. The other showed no effect of paroxetine on depression or pain. Patients on SSRI, however, reduced the amount of analgesic medication.
- Conditions
- Low Back Pain, Depression
- Being tested
- Escitalopram, Placebo
- Keywords
- Low back pain, Depression
- Medical subject headings
- Low Back Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Cipralex
Escitalopram 10mg per day for the first week, then 20mg per day till the end of study.
PlaceboDrug
Placebo 10mg per day for the first week, then 20mg per day till the end of study.
| Study group | Role | What they receive |
|---|---|---|
| A, 2, II | Placebo comparator | Placebo 10mg per day for the first week, then 20mg per day till the end of study. Receives: Drug: Placebo |
| A, 1 | Experimental | Escitalopram 10mg per day for the first week, then 20mg per day till the end of study. Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
In comparison to placebo-treated patients, patients with treated with Cipralex report a significant reduction in depressive symptoms (>= 50% HAMD score) after 4 weeks of treatment.
Measured: 4 weeks
Secondary outcomes (4)
In comparison to placebo, subjects treated with Cipralex report a significant reduction in pain intensity (>= 50% reduction of pain questionnaire score or VAS) after 12 weeks of treatment.
Measured: 12 weeks
In comparison with placebo, subjects treated with Cipralex report a significant improvement in physical and everyday functioning after 12 weeks of treatment.
Measured: 12 weeks
Personality traits do not have a significant influence on outcome regarding depressive traits, pain intensity and functioning.
Measured: 12 weeks
Personality disorders are significantly influencing worse outcome regarding depressive traits, pain intensity and functioning.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startNov 2007
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: Mutual agreement between Sponsor and Investigator.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Preuss, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Ulrich W Preuss, MD, Principal investigator, Krankenhaus Bethanien gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00227292
- Sponsor's protocol ID
- EudraCT Nr.2005-001673-10
- Other IDs
- JOS 05/01
- Status last verified
- Jun 2014
- First submitted
- 26 Sep 2005
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Dickens C, Jayson M, Sutton C, Creed F. The relationship between pain and depression in a trial using paroxetine in sufferers of chronic low back pain. Psychosomatics. 2000 Nov-Dec;41(6):490-9. doi: 10.1176/appi.psy.41.6.490.
PubMed 11110112Atkinson JH, Slater MA, Wahlgren DR, Williams RA, Zisook S, Pruitt SD, Epping-Jordan JE, Patterson TL, Grant I, Abramson I, Garfin SR. Effects of noradrenergic and serotonergic antidepressants on chronic low back pain intensity. Pain. 1999 Nov;83(2):137-45. doi: 10.1016/s0304-3959(99)00082-2.
PubMed 10534584
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cipralex in Treatment of Depressive Symptoms and Chronic Back Pain
- ClinicalTrials.gov ID
- NCT00227292
- Acronym / sponsor ID
- EudraCT Nr.2005-001673-10
- Conditions
- Low Back Pain, Depression
- Keywords
- Low back pain, Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Mutual agreement between Sponsor and Investigator.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 28 Sep 2005 (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.
Chronic low back pain (CLBP) is one of the most frequent forms of chronic pain and can result in significant functional impairment. This is often associated with major depression too. Previous research reported significant beneficial effects of antidepressant medication in alleviating depression and pain intensity. The aim of this study is to evaluate the efficacy of Escitalopram, a new kind of Selective Serotonin Reuptake Inhibitor (SSRI) in patients with CLBP in a prospective, randomized and double-blind clinical trial. The main hypothesis is:
-in comparison to placebo, subjects with CLBP and Cipralex report a significant reduction in depressive symptoms (>= 50% of HAMD questionnaire) after 4 weeks of treatment.
Detailed description
Pain is an unpleasant sensory and emotional experience. Chronic pain, including chronic low back pain, represents a major public health problem. Risk factors of chronicity of low back pain include high levels of psychological distress prior to or during the episode, premorbid association with work status or employment dissatisfaction, unemployment, poor self-rated health and low levels of physical activity. Other psychosocial features are poor social and educational status, previous sexual or physical abuse. Furthermore, mechanical strain on the spine from heavy lifting, repetitive lifting, twisting and vibration, including driving increase the risk. Static work postures, prolonged standing or walking, road traffic accidents and falls are also significantly related.While there is little evidence for a specific personality profile, stress, distress, anxiety, mood disorders and depression were consistently related to neck and back pain.
CLBP is associated with significant disability, functional impairment, high rates of psychiatric symptoms including anxiety and depression, and loss of other physical roles. These may produce social and functional problems, which include reduced earning capacity, unemployment and family disharmony. Chronic pain is also associated with loss of self confidence and self-esteem, leading to social withdrawal and social isolation. Men with CLBP have significantly higher lifetime rates of major depression, alcohol use disorder and major anxiety disorder. After age of pain onset, CLBP subjects had over 9 times the risk of developing major depression.
Depression is believed to be mediated by 5-HT and norepinephrine through the raphe nucleus and locus coeruleus projections to the cerebral cortex and forebrain limbic systems, whereas pain is believed to be mediated in part through descending 5-HT and norepinephrine pain pathways that provide inhibitory input to the dorsal horn neurons in the spinal cord. Global deficiences in 5-HT or norepinephrine neurotransmission would be predicted to affect both mood and pain thresholds, possibly accounting for the hgh comorbidity of painful symptoms in patients with depression.Accordingly, enhancement of both neurotransmitter or 5-HT alone would be expected both to improve symptoms of depression and to normalize pain thresholds.
In antidepressant treatment of CLBP, only 2 studies were published using SSRIs. One reported significantly higher pain intensity reduction in maprotilin group compared to paroxetine and placebo. The other showed no effect of paroxetine on depression or pain. Patients on SSRI, however, reduced the amount of analgesic medication.
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 |
|---|---|---|
| A, 2, II | Placebo comparator | Drug: PlaceboPlacebo 10mg per day for the first week, then 20mg per day till the end of study. |
| A, 1 | Experimental | Drug: EscitalopramEscitalopram 10mg per day for the first week, then 20mg per day till the end of study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- In- and out-patients at KH Bethanien, Greifswald, presenting with non-specific chronic low back pain lasting longer than 6 months (assessed with VAS and OLBPQ rev.)
- Age from 18 to 65 years
- Depressive symptoms (HAMD scores >10)
- Significant disability in daily living tasks (Owestry Disability Index >30%)
- Medication with nonsteroidal anti-inflammatory drugs.
Key exclusion criteria (6 listed)
- Other significant Axis I disorders, including psychosis, eating disorders, substance use disorders or recent suicidal behavior.
- Systemic inflammatory disorder, malignancy, other acute medical or neurological disorders, recent surgery within 12 months.
- Medication with opioids, corticosteroids, other psychotropic medication except Temazepam.
- History of gastric ulcer, gastritis or gastric bleeding.
- Known allergy or intolerance to Citalopram or Cipralex.
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 |
|---|---|---|
| EscitalopramAlso: CipralexEscitalopram 10mg per day for the first week, then 20mg per day till the end of study. | Drug | A, 1 |
| PlaceboPlacebo 10mg per day for the first week, then 20mg per day till the end of study. | Drug | A, 2, II |
Primary outcome
In comparison to placebo-treated patients, patients with treated with Cipralex report a significant reduction in depressive symptoms (>= 50% HAMD score) after 4 weeks of treatment.
Time frame: 4 weeks
4 secondary outcomes
In comparison to placebo, subjects treated with Cipralex report a significant reduction in pain intensity (>= 50% reduction of pain questionnaire score or VAS) after 12 weeks of treatment.
Time frame: 12 weeks
In comparison with placebo, subjects treated with Cipralex report a significant improvement in physical and everyday functioning after 12 weeks of treatment.
Time frame: 12 weeks
Personality traits do not have a significant influence on outcome regarding depressive traits, pain intensity and functioning.
Time frame: 12 weeks
Personality disorders are significantly influencing worse outcome regarding depressive traits, pain intensity and functioning.
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
- Results publication: PubMed 11110112Dickens C, Jayson M, Sutton C, Creed F. The relationship between pain and depression in a trial using paroxetine in sufferers of chronic low back pain. Psychosomatics. 2000 Nov-Dec;41(6):490-9. doi: 10.1176/appi.psy.41.6.490.
- Results publication: PubMed 10534584Atkinson JH, Slater MA, Wahlgren DR, Williams RA, Zisook S, Pruitt SD, Epping-Jordan JE, Patterson TL, Grant I, Abramson I, Garfin SR. Effects of noradrenergic and serotonergic antidepressants on chronic low back pain intensity. Pain. 1999 Nov;83(2):137-45. doi: 10.1016/s0304-3959(99)00082-2.
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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.
Ulrich W Preuss, MD principal investigator
Krankenhaus Bethanien gGmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Escitalopram in people with Low Back Pain and Depression, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
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 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: withdrawn, as of the sponsor's last update on 17 Jun 2014. 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 Germany. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
In comparison to placebo-treated patients, patients with treated with Cipralex report a significant reduction in depressive symptoms (>= 50% HAMD score) after 4 weeks of treatment. (time frame: 4 weeks). 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 NCT00227292, which also lists 2 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 17 Jun 2014.