Breast CancerPhase 2CAMADNCT05063604
Antidepressant Efficacy of Psychotherapy and Citalopram in Patients With Breast Cancer and Major Depression
A Phase 2 study testing Citalopram and Psychotherapy in people with Breast Cancer and Major Depressive Episode, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
To provide evidence on the antidepressant efficacy of two therapeutic treatments: pharmacological treatment (citalopram) and psychotherapy treatment, in women diagnosed with breast cancer and major depression. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Major Depressive Episode
- What is being tested?
- Citalopram and Psychotherapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 10 May 2022to 29 Jun 2022
- Phase
- Phase 2
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients first time diagnosed with breast cancer (stage I, II, III, or IV) between ages 18 and 75 (both inclusive).
- Patients with a "moderate-severe" level of emotional distress who meet the diagnostic criteria for major depression for at least two weeks or adjustment disorder with depressive mood for at least two months, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria (DSM-V), during the twelve months following the diagnose of breast cancer.
- Informed Consent Form Signature
Who cannot join
- Women who are pregnant or breastfeeding.
- Suicide risk.
- Metastatic brain disease.
- Personal History of oncological disease.
- Personal History of serious somatic disease (cardiac, hepatic, respiratory, endocrinological, neurological and haematological).
- Personal History of organic brain disorder, substance abuse/dependence.
Show all 10Show fewer
- Personal History of psychotic disorder, bipolar disorder and/or mental retardation.
- Contraindications of citalopram treatment.
- Taking antidepressants after the breast cancer diagnosis.
- Psychotherapy treatment after breast cancer diagnosis .
Trial locations and contacts
1 site in 1 country.
Spain1 site
Catalan Institute of Oncology
L'Hospitalet de Llobregat, Barcelona, 08908
About this study
Official title: Randomized, Controlled, Open and Unicentric Phase II Clinical Trial, With Two Parallel Groups, to Evaluate the Antidepressant Efficacy of Psychotherapy and Citalopram in Women Diagnosed With Breast Cancer and Major Depression
To provide evidence on the antidepressant efficacy of two therapeutic treatments: pharmacological treatment (citalopram) and psychotherapy treatment, in women diagnosed with breast cancer and major depression.
- Conditions
- Breast Cancer, Major Depressive Episode
- Being tested
- Citalopram, Psychotherapy
- Keywords
- Breast Cancer, Major Depressive Episode, Antidepressant Efficacy, Psychotherapy, Citalopram
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CitalopramDrug
Also called Prisdal
20 mg tablet one or twice daily for 12 weeks
PsychotherapyBehavioural
One session weekly for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Citalopram 20-40 mg | Experimental | Participants received citalopram 20 mg tablet once or twice daily for 12 weeks. Receives: Drug: Citalopram |
| Psychotherapy | Experimental | Participants received one psychotherapy session weekly for 12 weeks. Receives: Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in severity of depression on the Beck Depression Inventory (BDI) at week 12.
The BDI is a validated, self-reported instrument assessing the severity of depression. Scoring range 0-9 indicates minimal depression, 10-18 mild depression, 19-29 moderate depression, and 30-63 severe depression.
Measured: Every three weeks from baseline to the end of the study at week 12 (5 assessments in total).
Secondary outcomes (10)
Change from Baseline in quality of life on the European Quality of Life Scale Five Dimensions and Three Levels (EQ-5D-3L) at week 12.
The EQ-5D-3L is a standardized measure of health-related quality of life. The EQ-5D descriptive system comprises five dimensions with three levels of severity: 1 indicates no problems, 2 some problems, and 3 extreme problems.
Measured: Baseline and week 12.
Change from Baseline in social-labor adaptation measured by number of days off work at week 12.
Number of days off work.
Measured: Every three weeks from baseline to the end of the study at week 12 (5 assessments in total).
Age of patients.
Measured in years.
Measured: Baseline.
Marital status.
Percentage of patients single, married, widowed, separated or divorced collected by a clinical interview.
Measured: Baseline.
Cancer treatment received.
Percentage of patients treated with surgery, radiotherapy, chemotherapy and/or hormonal therapy. This treatment information will be collected from the medical record.
Measured: Baseline.
Breast cancer stage.
Breast cancer stage is expressed as a number on a scale from 0 to IV, where 0 describes non-invasive cancers that remain within their original location, and IV describes invasive cancers that have spread outside the breast to other parts of the body. This clinical information will be collected from the medical record.
Measured: Baseline.
Basal whole-brain activity by performing a functional Magnetic Resonance Imaging (fMRI).
fMRI is a specialized form of magnetic resonance imaging used to examine regional brain activity, allowing the identification of the brain areas allegedly underpinning psychological processes. fMRI uses a specific imaging sequence (echo planar imaging) to measure small changes in blood oxygenation by assessing the so-called blood oxygenation level dependent (BOLD) signal over time, which is linked to regional neuronal function.
Measured: fMRI at baseline.
Change from baseline in emotional processing on the Dot-Probe Task (DPT).
The DPT is a validated task to assess emotional processing by measuring reaction time to two types of stimuli (emotional face vs. neutral face), each one displayed on a different side of the screen. A faster reaction to emotional stimuli than to neutral ones indicates a bias of attention towards the emotional face and reflects dysfunction on emotional processing.
Measured: DPT at baseline and week 12.
Cost-effectiveness ratio differences between pharmacological treatment with citalopram and psychological treatment in patients in our environment with breast cancer (BC) and major depression (MD).
Analyze the cost of several variables, including both treatments (pharmacological and psychological), use of infrastructures and travel costs (only the first inclusion visit will be in person, the subsequent follow-up will be online).
Measured: At week 12.
Number and severity of secondary side effects related to the consumption of pharmacological treatment with citalopram according to the side effects rating scale Udvalg für Kliniske Undersogelser (UKU).
The UKU side effects scale is designed to evaluate the secondary effects derived from the consumption of psychotropic drugs. The UKU scale comprises a total of 54 items that describe 54 side effects. Each item takes a value from 0 to 3 (0, no or doubtful present; 1, mild; 2, moderate; 3, severe).
Measured: At week 3, 6, 9 and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start10 May 2022
- Primary completion10 May 2022
- Study completion29 Jun 2022
Why it stopped: The CAMAD clinical trial has been terminated due to difficulties in recruiting patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Català d'Oncologia
- Responsible party
- Principal investigator, Cinto Segalàs Cosi, MD, Hospital Universitari de Bellvitge
- Investigators
- Cinto Segalàs, MD, PhD., Principal investigator, Psychiatrist at the Bellvitge University Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063604
- Sponsor's protocol ID
- HUB-PSI-CAMAD
- Other IDs
- 2019-004548-31, 2019
- Acronym
- CAMAD
- Status last verified
- Jun 2022
- First submitted
- 27 Jul 2021
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fann JR, Thomas-Rich AM, Katon WJ, Cowley D, Pepping M, McGregor BA, Gralow J. Major depression after breast cancer: a review of epidemiology and treatment. Gen Hosp Psychiatry. 2008 Mar-Apr;30(2):112-26. doi: 10.1016/j.genhosppsych.2007.10.008.
PubMed 18291293Vodermaier A, Linden W, Rnic K, Young SN, Ng A, Ditsch N, Olson R. Prospective associations of depression with survival: a population-based cohort study in patients with newly diagnosed breast cancer. Breast Cancer Res Treat. 2014 Jan;143(2):373-84. doi: 10.1007/s10549-013-2795-4. Epub 2013 Dec 13.
PubMed 24337537Miguel C, Albuquerque E. Drug interaction in psycho-oncology: antidepressants and antineoplastics. Pharmacology. 2011;88(5-6):333-9. doi: 10.1159/000334738. Epub 2011 Nov 26.
PubMed 22123153Ochoa, C., & Casellas-Grau, A. (2015). Positive Psychotherapy in Cancer: Facilitating Posttraumatic Growth in Assimilation and Accomodation of Traumatic Experience. In C.R. Martin, V. R. Preedy & B. P.Vinood (Eds.). Comprehensive Guide to Post-Traumatic Stress Disorder (pp.113-127). Verna: Springer International Publishing Switzerland.
Godlewska BR, Browning M, Norbury R, Igoumenou A, Cowen PJ, Harmer CJ. Predicting Treatment Response in Depression: The Role of Anterior Cingulate Cortex. Int J Neuropsychopharmacol. 2018 Nov 1;21(11):988-996. doi: 10.1093/ijnp/pyy069.
PubMed 30124867Victor TA, Furey ML, Fromm SJ, Ohman A, Drevets WC. Relationship between amygdala responses to masked faces and mood state and treatment in major depressive disorder. Arch Gen Psychiatry. 2010 Nov;67(11):1128-38. doi: 10.1001/archgenpsychiatry.2010.144.
PubMed 21041614Victor TA, Furey ML, Fromm SJ, Ohman A, Drevets WC. Changes in the neural correlates of implicit emotional face processing during antidepressant treatment in major depressive disorder. Int J Neuropsychopharmacol. 2013 Nov;16(10):2195-208. doi: 10.1017/S146114571300062X. Epub 2013 Jul 1.
PubMed 23809145Avis NE, Levine B, Naughton MJ, Case LD, Naftalis E, Van Zee KJ. Age-related longitudinal changes in depressive symptoms following breast cancer diagnosis and treatment. Breast Cancer Res Treat. 2013 May;139(1):199-206. doi: 10.1007/s10549-013-2513-2. Epub 2013 Apr 16.
PubMed 23588951BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
PubMed 13688369
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Open and Unicentric Phase II Clinical Trial, With Two Parallel Groups, to Evaluate the Antidepressant Efficacy of Psychotherapy and Citalopram in Women Diagnosed With Breast Cancer and Major Depression
- ClinicalTrials.gov ID
- NCT05063604
- Acronym / sponsor ID
- CAMAD / HUB-PSI-CAMAD
- Conditions
- Breast Cancer, Major Depressive Episode
- Keywords
- Breast Cancer, Major Depressive Episode, Antidepressant Efficacy, Psychotherapy, Citalopram
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The CAMAD clinical trial has been terminated due to difficulties in recruiting patients.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Collaborators
- Institut Català d'Oncologia
- Study start
- 10 May 2022 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 1 Oct 2021 (actual)
- 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.
To provide evidence on the antidepressant efficacy of two therapeutic treatments: pharmacological treatment (citalopram) and psychotherapy treatment, in women diagnosed with breast cancer and major depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citalopram 20-40 mg | Experimental | Drug: CitalopramParticipants received citalopram 20 mg tablet once or twice daily for 12 weeks. |
| Psychotherapy | Experimental | Behavioral: PsychotherapyParticipants received one psychotherapy session weekly for 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients first time diagnosed with breast cancer (stage I, II, III, or IV) between ages 18 and 75 (both inclusive).
- Patients with a "moderate-severe" level of emotional distress who meet the diagnostic criteria for major depression for at least two weeks or adjustment disorder with depressive mood for at least two months, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria (DSM-V), during the twelve months following the diagnose of breast cancer.
- Informed Consent Form Signature
Key exclusion criteria (10 listed)
- Women who are pregnant or breastfeeding.
- Suicide risk.
- Metastatic brain disease.
- Personal History of oncological disease.
- Personal History of serious somatic disease (cardiac, hepatic, respiratory, endocrinological, neurological and haematological).
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 |
|---|---|---|
| CitalopramAlso: Prisdal20 mg tablet one or twice daily for 12 weeks | Drug | Citalopram 20-40 mg |
| PsychotherapyOne session weekly for 12 weeks | Behavioural | Psychotherapy |
Primary outcome
Change from Baseline in severity of depression on the Beck Depression Inventory (BDI) at week 12.
Time frame: Every three weeks from baseline to the end of the study at week 12 (5 assessments in total).
The BDI is a validated, self-reported instrument assessing the severity of depression. Scoring range 0-9 indicates minimal depression, 10-18 mild depression, 19-29 moderate depression, and 30-63 severe depression.
10 secondary outcomes
Change from Baseline in quality of life on the European Quality of Life Scale Five Dimensions and Three Levels (EQ-5D-3L) at week 12.
Time frame: Baseline and week 12.
Change from Baseline in social-labor adaptation measured by number of days off work at week 12.
Time frame: Every three weeks from baseline to the end of the study at week 12 (5 assessments in total).
Age of patients.
Time frame: Baseline.
Marital status.
Time frame: Baseline.
Cancer treatment received.
Time frame: Baseline.
Breast cancer stage.
Time frame: Baseline.
Basal whole-brain activity by performing a functional Magnetic Resonance Imaging (fMRI).
Time frame: fMRI at baseline.
Change from baseline in emotional processing on the Dot-Probe Task (DPT).
Time frame: DPT at baseline and week 12.
Cost-effectiveness ratio differences between pharmacological treatment with citalopram and psychological treatment in patients in our environment with breast cancer (BC) and major depression (MD).
Time frame: At week 12.
Number and severity of secondary side effects related to the consumption of pharmacological treatment with citalopram according to the side effects rating scale Udvalg für Kliniske Undersogelser (UKU).
Time frame: At week 3, 6, 9 and 12.
Results and safety
The study was stopped early (reason given: The CAMAD clinical trial has been terminated due to difficulties in recruiting patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Results publication: PubMed 18291293Fann JR, Thomas-Rich AM, Katon WJ, Cowley D, Pepping M, McGregor BA, Gralow J. Major depression after breast cancer: a review of epidemiology and treatment. Gen Hosp Psychiatry. 2008 Mar-Apr;30(2):112-26. doi: 10.1016/j.genhosppsych.2007.10.008.
- Results publication: PubMed 24337537Vodermaier A, Linden W, Rnic K, Young SN, Ng A, Ditsch N, Olson R. Prospective associations of depression with survival: a population-based cohort study in patients with newly diagnosed breast cancer. Breast Cancer Res Treat. 2014 Jan;143(2):373-84. doi: 10.1007/s10549-013-2795-4. Epub 2013 Dec 13.
- Results publication: PubMed 22123153Miguel C, Albuquerque E. Drug interaction in psycho-oncology: antidepressants and antineoplastics. Pharmacology. 2011;88(5-6):333-9. doi: 10.1159/000334738. Epub 2011 Nov 26.
- Results publicationOchoa, C., & Casellas-Grau, A. (2015). Positive Psychotherapy in Cancer: Facilitating Posttraumatic Growth in Assimilation and Accomodation of Traumatic Experience. In C.R. Martin, V. R. Preedy & B. P.Vinood (Eds.). Comprehensive Guide to Post-Traumatic Stress Disorder (pp.113-127). Verna: Springer International Publishing Switzerland.
- Results publication: PubMed 30124867Godlewska BR, Browning M, Norbury R, Igoumenou A, Cowen PJ, Harmer CJ. Predicting Treatment Response in Depression: The Role of Anterior Cingulate Cortex. Int J Neuropsychopharmacol. 2018 Nov 1;21(11):988-996. doi: 10.1093/ijnp/pyy069.
- Results publication: PubMed 21041614Victor TA, Furey ML, Fromm SJ, Ohman A, Drevets WC. Relationship between amygdala responses to masked faces and mood state and treatment in major depressive disorder. Arch Gen Psychiatry. 2010 Nov;67(11):1128-38. doi: 10.1001/archgenpsychiatry.2010.144.
- Results publication: PubMed 23809145Victor TA, Furey ML, Fromm SJ, Ohman A, Drevets WC. Changes in the neural correlates of implicit emotional face processing during antidepressant treatment in major depressive disorder. Int J Neuropsychopharmacol. 2013 Nov;16(10):2195-208. doi: 10.1017/S146114571300062X. Epub 2013 Jul 1.
- Results publication: PubMed 23588951Avis NE, Levine B, Naughton MJ, Case LD, Naftalis E, Van Zee KJ. Age-related longitudinal changes in depressive symptoms following breast cancer diagnosis and treatment. Breast Cancer Res Treat. 2013 May;139(1):199-206. doi: 10.1007/s10549-013-2513-2. Epub 2013 Apr 16.
- Results publication: PubMed 13688369BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
- Citalopram technical data sheet.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Cinto Segalàs, MD, PhD. principal investigator
Psychiatrist at the Bellvitge University Hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Citalopram and Psychotherapy in people with Breast Cancer and Major Depressive Episode, run by Hospital Universitari de Bellvitge at 1 site in Spain.
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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 5 Jul 2022. 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 Spain. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 stopped early (reason given: The CAMAD clinical trial has been terminated due to difficulties in recruiting patients.). 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?
Change from Baseline in severity of depression on the Beck Depression Inventory (BDI) at week 12. (time frame: Every three weeks from baseline to the end of the study at week 12 (5 assessments in total).). 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 NCT05063604, which also lists 9 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 Jul 2022.