Psychotherapy for Persistent Depressive Disorder

Nova Scotia Health Authority, Halifax, Canada
Persistent Depressive Disorder+1 More ConditionsCognitive Behavioral Therapy - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trialwill test if certain clinical factors & biomarkers predict better response to antidepressant medication or cognitive-behavioural therapy for depression, allowing for personalized treatment & improved outcomes.

Eligible Conditions
  • Depression
  • Persistent Depressive Disorder

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

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Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 2-52 weeks

2-52 weeks
Global-Clinical Impression scale (GCI)
Quick Inventory of Depressive Symptoms (QIDS-SR)
Total score on the Montgomery Asberg Depression Rating Scale (MADRS)

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

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1
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Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

Psychotherapy
1 of 2
Pharmacotherapy
1 of 2

Experimental Treatment

360 Total Participants · 2 Treatment Groups

Primary Treatment: Psychotherapy · No Placebo Group · Phase 4

Psychotherapy
Behavioral
Experimental Group · 1 Intervention: Cognitive Behavioral Therapy · Intervention Types: Behavioral
Pharmacotherapy
Drug
Experimental Group · 1 Intervention: Pharmacotherapy · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy
2016
Completed Phase 4
~3130
Pharmacotherapy
2003
Completed Phase 4
~1590

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2-52 weeks

Who is running the clinical trial?

University Health Network, TorontoOTHER
1,396 Previous Clinical Trials
474,023 Total Patients Enrolled
Centre for Addiction and Mental HealthOTHER
330 Previous Clinical Trials
76,998 Total Patients Enrolled
Queen's UniversityOTHER
346 Previous Clinical Trials
111,753 Total Patients Enrolled
Nova Scotia Health AuthorityLead Sponsor
243 Previous Clinical Trials
82,402 Total Patients Enrolled
Rudolf Uher, MD, PhDPrincipal InvestigatorNova Scotia Health Authority
4 Previous Clinical Trials
30,524 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been experiencing depression for at least two months continuously. This means that short, temporary feelings of depression will not be included. You are 18 years or older.
References

Frequently Asked Questions

How many participants are actively participating in this experiment?

"Affirmative. Clinicaltrials.gov documents suggest that this experiment is presently enrolling participants and has been since October 31st 2016, with the latest update occurring on February 6th 2023. The trial requires a total of 360 enrollees from 1 medical facility to be completed successfully." - Anonymous Online Contributor

Unverified Answer

Has the FDA issued a stamp of approval for psychotherapeutic treatments?

"With a score of 3, psychotherapy has been deemed safe based on the results from its Phase 4 trial. This signifies that this treatment is officially approved for usage." - Anonymous Online Contributor

Unverified Answer

Are there any opportunities to join this investigation currently available?

"Affirmative. As evidenced on clinicaltrials.gov, the trial which was first listed in October of 2016 is still actively recruiting patients today. 360 individuals are sought from one medical site for this investigation and it has been updated as recently as February 6th 2023." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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