Major DepressionODSNCT02520271
Ostrobothnia Depression Study (ODS). A Naturalistic Follow-up Study on Depression and Related Substance Use Disorders
A study testing Behavioral Activation and Motivational Interview in people with Major Depression and Dual Diagnosis, run by Seinajoki Central Hospital at 1 site in Finland.
Trial summary
Ostrobothnia Depression Study (ODS) was conducted in the South Ostrobothnia hospital district of Finland during 2009-2014. ODS is a naturalistic, open label, non-randomized follow-up study on depression and related substance use disorders (SUD). Read more about this study
- Who is it for?
- Ages 17 to 65 years
- Conditions the study is for
- Major Depression, Dual Diagnosis, Anxiety Disorders
- What is being tested?
- Behavioral Activation and Motivational Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2009to Jun 2014
- 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 17 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients referred to psychiatric secondary services because of
- Depressive symptoms
- Anxiety
- Self-destructiveness
- Insomnia
- Alcohol or other substance related problems, and had Beck depression inventory (BDI, version 1A) score at least 17 at the screening phase.
Who cannot join
- A likely or verified ICD-10 F2 category diagnosis (psychotic disorders).
- Organic brain disease
Trial locations and contacts
1 site in 1 country.
Finland1 site
Seinäjoki Hospital District
Seinäjoki, South Ostrobothnia, 60220
About this study
Official title: ODS is a Naturalistic, Open Label, Non-randomized Follow-up Study on Depression and Related Substance Use Disorders (SUD). Study Targets: Efficacy of Psychosocial Treatment, Pharmacogenetics, Inflammation Related Biomarkers
Ostrobothnia Depression Study (ODS) was conducted in the South Ostrobothnia hospital district of Finland during 2009-2014. ODS is a naturalistic, open label, non-randomized follow-up study on depression and related substance use disorders (SUD). The study focuses on several aspects concerning the relation of depression and SUDs, the efficacy of selected assessment and treatment protocols, characteristics and genetics of the participants and the use of related biomarkers in clinical practice. The misused substance in focus is alcohol. In this study, dual diagnosis (DD) is defined as the simultaneous presence of clinically diagnosed major depressive disorder (MDD) and alcohol use disorder (AUD). The study was approved by the local ethics committee. Written informed consent was collected from all participants.
Read the detailed description
Participants The participants were recruited in five outpatient clinics and in one psychiatric hospital ward in the South Ostrobothnia hospital district (population 200,000) during 1.10.2009 - 31.10.2013. Patients referred to psychiatric secondary services because of depressive symptoms, anxiety, self destructiveness, insomnia and alcohol or other substance related problems were screened with Beck depression inventory (BDI, version 1A). Patients with BDI score ≥ 17 at the screening phase were recruited in the study. The patients with a likely or verified psychotic disorders (ICD-10, F2*.** diagnosis) or organic brain disease were excluded.
A total of 242 patients were included in the study. Fifty-three (21.9%) patients were hospitalised at baseline. The participants were aged 17-64 years (mean 38.8 years, SD 12.2). Among the recruited were 148 females (61.2%) and 94 males (38.8%). The Mini International Neuropsychiatric Interview 5.0 (MINI) was made at the baseline to 219 patients.
At baseline 203 (84%) patients were prescribed antidepressive medication, 81% of cases either SSRI or SNRI as primary antidepressant). Antipsychotic medication was prescribed to 66 (28%) patients.
At the time of recruitment the participants were divided in two groups based on the AUDIT -score. The patients with baseline AUDIT-score ≥ 11 were categorized as patients with comorbid AUD and therefore dual diagnosis (DD+). The patients with AUDIT ≤ 10 were categorized as (DD-).
The clinical psychiatric evaluation was performed by a psychiatrist or other trained professional using the Mini International Neuropsychiatric Interview 5.0 (MINI). The symptoms of MDD were assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS).
The patients received medication if the need for medical treatment was assessed by the psychiatrist responsible of the treatment. The use of psychotropic medications was recorded. The choice of medication was left for the clinician in charge.
All participants were also evaluated by three-dimensional model to select the following treatment intervention. The model has been developed by Kampman and Lassila in South Ostrobothnia hospital district and described in more detail in Finnish Medical Journal. The model was developed based on the need to have tools to better assess the patients with DD in clinical setting. The model can be used for defining the patients' problem according to three treatment related factors (diagnosis, substance use problem, level of functioning). The model consists of three dichotomous assessments each leading to score of 0 or 1 points according to difficulty of the problem. The factors assessed are 1) psychiatric diagnosis (non-psychotic/psychotic; 0/1 points), 2) difficulty of SUD (moderate/difficult; 0/1 points) and 3) patients level of functioning according to Global Assessment of Functioning (GAF) -scale (good functioning/poor functioning; 0/1 points). The given points are then added together to form an overall score from 0 points (modest DD problem) to 3 points (most difficult DD problem).
Treatment interventions The treatment interventions included antidepressive medication (SSRI or other), Behavioral Activation therapy (BA) and FRAMES intervention, and Motivational interview (MI) In participants with AUDIT ≤ 10 (DD-) the intervention started with focus on depression (antidepressive medication and BA). In patients with AUDIT ≥ 11 (DD+) the intervention started with focus on AUD. If AUD was evaluated as moderate (duration less than 2 years, most of the days sober during the last month) the first treatment selected could be either FRAMES or MI. If AUD was assessed to be severe (duration more than 2 years, active use most of the days during last month, poly-substance use, GAF < 50) the intervention was supposed to start with MI. The intervention was implemented by the staff person responsible of the appointments of certain patient (a nurse or a psychologist) who had received training for the use of selected interventions. The duration of MI was set to approximately 3 (2-5) appointments. The minimum duration of BA was set to 4 appointments.
Follow-up The follow-up included appointments with clinical research nurse at 6, 12 and 24 months points. During these appointments the severity of and the recovery from depression was evaluated by MADRS, alcohol use was evaluated by AUDIT, the information on substance use relapses was collected, and the MINI-interview was repeated at 12 months point. Additionally, the following information was collected: 15D-quality of life scale, GAF-scale, laboratory tests (at 6 months: a blood count, electrolytes, creatinine, liver function), Body Mass Index, waist, smoking status.
- Being tested
- Behavioral Activation, Motivational Interview
- Keywords
- Mood Disorders, Motivational Interview, Behavioral Activation
- Medical subject headings
- Depressive Disorder, Major, Anxiety Disorders, Substance-Related Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ActivationBehavioural
Also called Behavioral Activation Therapy, Cognitive Behavioral Therapy
BA consists of at least 4 intervention sessions with a focused, active working style by the therapist. The therapy initiation includes a focused interview targeting at determining 1-2 main problems, on which the therapy will be focused. Specific therapeutic methods for BA include the use ABC analysis, targeting at hitting the negative consequences of current problematic behavior and motivating for change. Further, recognizing the obstacles for change (TRAP) is the next method to be used. The therapist encourages the client for active behavioral monitoring through assigned homework during the therapy process. The final step and method used is strengthening the gained change (ACTION).
Motivational InterviewBehavioural
Also called Motivational Interviewing
Motivational interview (MI) is a therapeutic intervention that focuses on resolving client ambivalence towards changing problematic behavior. MI involves a client-centered approach that encourages the client to develop his or her own motivation. The therapeutic alliance in MI is predominantly a partnership, rather than an expert/client dynamic.
MI has been studied primarily in addiction problems, but there are numerous reports of its efficacy in several chronic somatic conditions, and lifestyle problems.
| Study group | Role | What they receive |
|---|---|---|
| Depression | Active comparator | Behavioral activation only Receives: Behavioral: Behavioral Activation |
| Depression and SUD | Active comparator | Motivational interview and Behavioral activation Receives: Behavioral: Behavioral Activation; Behavioral: Motivational Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in severity of depressive symptoms from baseline at 6 weeks, 6 months, 12 months, and 24 months
Measure: MADRS depression scale
Measured: baseline, 6 weeks, 6 months, 12 months, 24 months
Secondary outcomes (3)
Change in quality of life from baseline at 6 weeks, 6 months, 12 months, and 24 months
Measure: 15D scale
Measured: baseline, 6 months, 12 months, 24 months
Change in number of weekly consumed alcohol drinks from baseline at 6 weeks, 6 months, 12 months, and 24 months
Measured: baseline, 6 weeks, 6 months, 12 months, 24 months
Change in severity of alcohol use from baseline at 6 weeks, 6 months, 12 months, and 24 months
Measure: AUDIT (Alcohol Use Disorders Identification Test)
Measured: baseline, 6 weeks, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startOct 2009
- Primary completionOct 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Major 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seinajoki Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University
- Responsible party
- Principal investigator, Olli Kampman, Seinajoki Central Hospital
- Investigators
- Olli Kampman, MD, PhD, Study director, Seinäjoki Hospital District, Department of Psychiatry and University of Tampere, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520271
- Sponsor's protocol ID
- EVO1114
- Acronym
- ODS
- Status last verified
- Aug 2015
- First submitted
- 27 Jun 2015
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Miller WR, Rollnick S. Ten things that motivational interviewing is not. Behav Cogn Psychother. 2009 Mar;37(2):129-40. doi: 10.1017/S1352465809005128.
PubMed 19364414Kanter JW, Manos RC, Bowe WM, Baruch DE, Busch AM, Rusch LC. What is behavioral activation? A review of the empirical literature. Clin Psychol Rev. 2010 Aug;30(6):608-20. doi: 10.1016/j.cpr.2010.04.001.
PubMed 20677369Kampman O, Lassila A. Samanaikaisen mielenterveys- ja päihdeongelman hoitoon on kehitetty integroitu arviointimalli [TI: An Integrated Assessment Method for Dual Diagnosis]. Suom Lääkäril 2007:4447-4451.[SO: Finnish Medical Journal, Finnish]
Luoto KE, Lassila A, Leinonen E, Kampman O. Predictors of short-term response and the role of heavy alcohol use in treatment of depression. BMC Psychiatry. 2023 Nov 27;23(1):880. doi: 10.1186/s12888-023-05366-8.
PubMed 38012573Archer M, Niemela O, Hamalainen M, Moilanen E, Leinonen E, Kampman O. The role of alcohol use and adiposity in serum levels of IL-1RA in depressed patients. BMC Psychiatry. 2022 Mar 2;22(1):158. doi: 10.1186/s12888-022-03784-8.
PubMed 35232419Luoto KE, Lindholm LH, Koivukangas A, Lassila A, Sintonen H, Leinonen E, Kampman O. Impact of Comorbid Alcohol Use Disorder on Health-Related Quality of Life Among Patients With Depressive Symptoms. Front Psychiatry. 2021 Oct 8;12:688136. doi: 10.3389/fpsyt.2021.688136. eCollection 2021.
PubMed 34690824Luoto KE, Lindholm LH, Paavonen V, Koivukangas A, Lassila A, Leinonen E, Kampman O. Behavioral activation versus treatment as usual in naturalistic sample of psychiatric patients with depressive symptoms: a benchmark controlled trial. BMC Psychiatry. 2018 Jul 27;18(1):238. doi: 10.1186/s12888-018-1820-x.
PubMed 30049272
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ODS is a Naturalistic, Open Label, Non-randomized Follow-up Study on Depression and Related Substance Use Disorders (SUD). Study Targets: Efficacy of Psychosocial Treatment, Pharmacogenetics, Inflammation Related Biomarkers
- ClinicalTrials.gov ID
- NCT02520271
- Acronym / sponsor ID
- ODS / EVO1114
- Keywords
- Mood Disorders, Motivational Interview, Behavioral Activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Seinajoki Central HospitalUniversity, hospital or other
- Collaborators
- Tampere University
- Study start
- Oct 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 11 Aug 2015 (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.
Ostrobothnia Depression Study (ODS) was conducted in the South Ostrobothnia hospital district of Finland during 2009-2014. ODS is a naturalistic, open label, non-randomized follow-up study on depression and related substance use disorders (SUD). The study focuses on several aspects concerning the relation of depression and SUDs, the efficacy of selected assessment and treatment protocols, characteristics and genetics of the participants and the use of related biomarkers in clinical practice. The misused substance in focus is alcohol. In this study, dual diagnosis (DD) is defined as the simultaneous presence of clinically diagnosed major depressive disorder (MDD) and alcohol use disorder (AUD). The study was approved by the local ethics committee. Written informed consent was collected from all participants.
Detailed description
Participants The participants were recruited in five outpatient clinics and in one psychiatric hospital ward in the South Ostrobothnia hospital district (population 200,000) during 1.10.2009 - 31.10.2013. Patients referred to psychiatric secondary services because of depressive symptoms, anxiety, self destructiveness, insomnia and alcohol or other substance related problems were screened with Beck depression inventory (BDI, version 1A). Patients with BDI score ≥ 17 at the screening phase were recruited in the study. The patients with a likely or verified psychotic disorders (ICD-10, F2*.** diagnosis) or organic brain disease were excluded.
A total of 242 patients were included in the study. Fifty-three (21.9%) patients were hospitalised at baseline. The participants were aged 17-64 years (mean 38.8 years, SD 12.2). Among the recruited were 148 females (61.2%) and 94 males (38.8%). The Mini International Neuropsychiatric Interview 5.0 (MINI) was made at the baseline to 219 patients.
At baseline 203 (84%) patients were prescribed antidepressive medication, 81% of cases either SSRI or SNRI as primary antidepressant). Antipsychotic medication was prescribed to 66 (28%) patients.
At the time of recruitment the participants were divided in two groups based on the AUDIT -score. The patients with baseline AUDIT-score ≥ 11 were categorized as patients with comorbid AUD and therefore dual diagnosis (DD+). The patients with AUDIT ≤ 10 were categorized as (DD-).
The clinical psychiatric evaluation was performed by a psychiatrist or other trained professional using the Mini International Neuropsychiatric Interview 5.0 (MINI). The symptoms of MDD were assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS).
The patients received medication if the need for medical treatment was assessed by the psychiatrist responsible of the treatment. The use of psychotropic medications was recorded. The choice of medication was left for the clinician in charge.
All participants were also evaluated by three-dimensional model to select the following treatment intervention. The model has been developed by Kampman and Lassila in South Ostrobothnia hospital district and described in more detail in Finnish Medical Journal. The model was developed based on the need to have tools to better assess the patients with DD in clinical setting. The model can be used for defining the patients' problem according to three treatment related factors (diagnosis, substance use problem, level of functioning). The model consists of three dichotomous assessments each leading to score of 0 or 1 points according to difficulty of the problem. The factors assessed are 1) psychiatric diagnosis (non-psychotic/psychotic; 0/1 points), 2) difficulty of SUD (moderate/difficult; 0/1 points) and 3) patients level of functioning according to Global Assessment of Functioning (GAF) -scale (good functioning/poor functioning; 0/1 points). The given points are then added together to form an overall score from 0 points (modest DD problem) to 3 points (most difficult DD problem).
Treatment interventions The treatment interventions included antidepressive medication (SSRI or other), Behavioral Activation therapy (BA) and FRAMES intervention, and Motivational interview (MI) In participants with AUDIT ≤ 10 (DD-) the intervention started with focus on depression (antidepressive medication and BA). In patients with AUDIT ≥ 11 (DD+) the intervention started with focus on AUD. If AUD was evaluated as moderate (duration less than 2 years, most of the days sober during the last month) the first treatment selected could be either FRAMES or MI. If AUD was assessed to be severe (duration more than 2 years, active use most of the days during last month, poly-substance use, GAF < 50) the intervention was supposed to start with MI. The intervention was implemented by the staff person responsible of the appointments of certain patient (a nurse or a psychologist) who had received training for the use of selected interventions. The duration of MI was set to approximately 3 (2-5) appointments. The minimum duration of BA was set to 4 appointments.
Follow-up The follow-up included appointments with clinical research nurse at 6, 12 and 24 months points. During these appointments the severity of and the recovery from depression was evaluated by MADRS, alcohol use was evaluated by AUDIT, the information on substance use relapses was collected, and the MINI-interview was repeated at 12 months point. Additionally, the following information was collected: 15D-quality of life scale, GAF-scale, laboratory tests (at 6 months: a blood count, electrolytes, creatinine, liver function), Body Mass Index, waist, smoking status.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depression | Active comparator | Behavioral: Behavioral ActivationBehavioral activation only |
| Depression and SUD | Active comparator | Behavioral: Behavioral Activation, Behavioral: Motivational InterviewMotivational interview and Behavioral activation |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients referred to psychiatric secondary services because of
- Depressive symptoms
- Anxiety
- Self-destructiveness
- Insomnia
Key exclusion criteria (2 listed)
- A likely or verified ICD-10 F2 category diagnosis (psychotic disorders).
- Organic brain disease
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 |
|---|---|---|
| Behavioral ActivationAlso: Behavioral Activation Therapy, Cognitive Behavioral TherapyBA consists of at least 4 intervention sessions with a focused, active working style by the therapist. The therapy initiation includes a focused interview targeting at determining 1-2 main problems, on which the therapy will be focused. Specific therapeutic methods for BA include the use ABC analysis, targeting at hitting the negative consequences of current problematic behavior and motivating for change. Further, recognizing the obstacles for change (TRAP) is the next method to be used. The therapist encourages the client for active behavioral monitoring through assigned homework during the therapy process. The final step and method used is strengthening the gained change (ACTION). | Behavioural | Depression, Depression and SUD |
| Motivational InterviewAlso: Motivational InterviewingMotivational interview (MI) is a therapeutic intervention that focuses on resolving client ambivalence towards changing problematic behavior. MI involves a client-centered approach that encourages the client to develop his or her own motivation. The therapeutic alliance in MI is predominantly a partnership, rather than an expert/client dynamic. MI has been studied primarily in addiction problems, but there are numerous reports of its efficacy in several chronic somatic conditions, and lifestyle problems. | Behavioural | Depression and SUD |
Primary outcome
Change in severity of depressive symptoms from baseline at 6 weeks, 6 months, 12 months, and 24 months
Time frame: baseline, 6 weeks, 6 months, 12 months, 24 months
Measure: MADRS depression scale
3 secondary outcomes
Change in quality of life from baseline at 6 weeks, 6 months, 12 months, and 24 months
Time frame: baseline, 6 months, 12 months, 24 months
Change in number of weekly consumed alcohol drinks from baseline at 6 weeks, 6 months, 12 months, and 24 months
Time frame: baseline, 6 weeks, 6 months, 12 months, 24 months
Change in severity of alcohol use from baseline at 6 weeks, 6 months, 12 months, and 24 months
Time frame: baseline, 6 weeks, 6 months, 12 months, 24 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 13 Aug 2015.
- Background: PubMed 19364414Miller WR, Rollnick S. Ten things that motivational interviewing is not. Behav Cogn Psychother. 2009 Mar;37(2):129-40. doi: 10.1017/S1352465809005128.
- Background: PubMed 20677369Kanter JW, Manos RC, Bowe WM, Baruch DE, Busch AM, Rusch LC. What is behavioral activation? A review of the empirical literature. Clin Psychol Rev. 2010 Aug;30(6):608-20. doi: 10.1016/j.cpr.2010.04.001.
- BackgroundKampman O, Lassila A. Samanaikaisen mielenterveys- ja päihdeongelman hoitoon on kehitetty integroitu arviointimalli [TI: An Integrated Assessment Method for Dual Diagnosis]. Suom Lääkäril 2007:4447-4451.[SO: Finnish Medical Journal, Finnish]
- Derived from this study: PubMed 38012573Luoto KE, Lassila A, Leinonen E, Kampman O. Predictors of short-term response and the role of heavy alcohol use in treatment of depression. BMC Psychiatry. 2023 Nov 27;23(1):880. doi: 10.1186/s12888-023-05366-8.
- Derived from this study: PubMed 35232419Archer M, Niemela O, Hamalainen M, Moilanen E, Leinonen E, Kampman O. The role of alcohol use and adiposity in serum levels of IL-1RA in depressed patients. BMC Psychiatry. 2022 Mar 2;22(1):158. doi: 10.1186/s12888-022-03784-8.
- Derived from this study: PubMed 34690824Luoto KE, Lindholm LH, Koivukangas A, Lassila A, Sintonen H, Leinonen E, Kampman O. Impact of Comorbid Alcohol Use Disorder on Health-Related Quality of Life Among Patients With Depressive Symptoms. Front Psychiatry. 2021 Oct 8;12:688136. doi: 10.3389/fpsyt.2021.688136. eCollection 2021.
- Derived from this study: PubMed 30049272Luoto KE, Lindholm LH, Paavonen V, Koivukangas A, Lassila A, Leinonen E, Kampman O. Behavioral activation versus treatment as usual in naturalistic sample of psychiatric patients with depressive symptoms: a benchmark controlled trial. BMC Psychiatry. 2018 Jul 27;18(1):238. doi: 10.1186/s12888-018-1820-x.
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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.
Olli Kampman, MD, PhD study director
Seinäjoki Hospital District, Department of Psychiatry and University of Tampere, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation and Motivational Interview in people with Major Depression and Dual Diagnosis, run by Seinajoki Central Hospital at 1 site in Finland.
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 6 inclusion and 2 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 13 Aug 2015. 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 Finland. 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?
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?
Change in severity of depressive symptoms from baseline at 6 weeks, 6 months, 12 months, and 24 months (time frame: baseline, 6 weeks, 6 months, 12 months, 24 months). 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 NCT02520271, which also lists 7 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 13 Aug 2015.