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DepressionPhase 3NCT00043550

Treatments for Depression: Drug Versus Psychotherapy

A Phase 3 study testing Supportive Expressive Therapy, Sertraline and Venlafaxine in people with Depression, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This 4-8 month study, with a 2-year follow up period, will compare sertraline (Zoloft®), venlafaxine (Effexor®), supportive-expressive psychotherapy, and placebo to determine which is more effective in treating major depression. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Depression
What is being tested?
Supportive Expressive Therapy, Sertraline and Venlafaxine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
156 participants
Where
1 siteUnited States
Study dates
Nov 2001to Jun 2009
Phase
Phase 3
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Major Depressive Disorder diagnosis

Who cannot join

  • Psychotic or bipolar disorder diagnosis
  • Substance dependence in the last 6 months

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Efficacy of Dynamic Therapy Versus Selective Serotonin Reuptake Inhibitor for Depression

This 4-8 month study, with a 2-year follow up period, will compare sertraline (Zoloft®), venlafaxine (Effexor®), supportive-expressive psychotherapy, and placebo to determine which is more effective in treating major depression.

Read the detailed description

MDD is one of the most prevalent psychiatric disorders. Different forms of psychotherapy for depression have been found effective. This study compares a form of dynamic psychotherapy called supportive-expressive psychotherapy to medication and to placebo.

Participants are evaluated on 2 occasions, 1 week apart, before they are randomly assigned to receive either supportive-expressive psychotherapy, sertraline (Zoloft) (followed by venlafaxine [Effexor] if patients do not respond to sertraline), or placebo. The active phase of treatment lasts 4 months. The frequency of patients' visits depends on the assigned treatment.

Patients who are randomized to receive medication or placebo are initially seen on a weekly basis, then less often, depending on the rate of symptomatic improvement. Patients who are randomized to psychotherapy are seen twice a week for the first 4 weeks, then once a week for the remaining 12 weeks. Outcome is monitored at week 2,4,6,7,8, 12, 15 and 16. At the end of the first 16 weeks of treatment, patients are thoroughly evaluated. Those who have responded to treatment are assigned to a continuation phase and are seen once a month for another 16 weeks. At the end of the 16-week continuation phase, patients are again evaluated and all treatments are stopped. Follow-up continues every 3 months for up to 2 years to ensure that the patients' depression remains under control.

Conditions
Depression
Being tested
Supportive Expressive Therapy, Sertraline, Pill Placebo, Venlafaxine
Keywords
Major Depressive Disorder
Medical subject headings
Depression, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supportive Expressive TherapyBehavioural

    The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship.

  • SertralineDrug

    Also called Zoloft

    Participants will receive sertraline.

  • Pill PlaceboDrug

    Participants will receive a pill placebo.

  • VenlafaxineDrug

    Also called Effexor

    Participants will receive venlafaxine.

Study groups in NCT00043550
Study groupRoleWhat they receive
1 Sertraline/VenlafaxineExperimentalParticipants receive sertraline for the first 8 weeks. Participants will receive venlafaxine if they do not respond to sertraline by week 8
Receives: Drug: Sertraline; Drug: Venlafaxine
2 Supportive Expressive TherapyActive comparatorParticipants will receive supportive-expressive psychotherapy.
Receives: Behavioral: Supportive Expressive Therapy
3 Pill PlaceboPlacebo comparatorParticipants receive placebo.
Receives: Drug: Pill Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hamilton Rating Scale for Depression-17 Item

    Hamilton Rating Scale for Depression (HRSD) (Hamilton, 1960). We used the 17-item version of the 27-item HRSD, a measure of depression severity. The Structured Interview Guide was used to conduct the interviews (SIGH-D; Williams, 1988). The reliability and validity of the HRSD are well documented (Rabkin \& Klein, 1987). Interjudge reliability as assessed by interclass correlations was .92 in our sample. Total 17-item scores could range from 17-48 with higher scores indicating greater distress.

    Measured: symptoms assessed during past 7 days, measure taken at baseline, week 8 and week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2002 (estimated)
  2. Study startNov 2001
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00043550
Sponsor's protocol ID
R01MH061410
Other IDs
R01MH061410, DSIR 83-ATAS
Status last verified
Apr 2017
First submitted
9 Aug 2002
Last updated
2 Jun 2017
Data monitoring committee
Yes

Publications

  • Barber JP, Muenz LR. The role of avoidance and obsessiveness in matching patients to cognitive and interpersonal psychotherapy: empirical findings from the treatment for depression collaborative research program. J Consult Clin Psychol. 1996 Oct;64(5):951-8. doi: 10.1037//0022-006x.64.5.951.

    PubMed 8916624

  • Kuprian N, Aafjes-van Doorn K, Gutterman D, Barber JP. Therapeutic immediacy in psychodynamic psychotherapy for depression: A mixed-method study. Psychotherapy (Chic). 2022 Dec;59(4):554-566. doi: 10.1037/pst0000452. Epub 2022 Aug 1.

    PubMed 35913883

  • Solomonov N, Falkenstrom F, Gorman BS, McCarthy KS, Milrod B, Rudden MG, Chambless DL, Barber JP. Differential effects of alliance and techniques on Panic-Specific Reflective Function and misinterpretation of bodily sensations in two treatments for panic. Psychother Res. 2020 Jan;30(1):97-111. doi: 10.1080/10503307.2019.1585591. Epub 2019 Mar 1.

    PubMed 30821630

  • Solomonov N, McCarthy KS, Gorman BS, Barber JP. The Multitheoretical List of Therapeutic Interventions - 30 items (MULTI-30). Psychother Res. 2019 Jul;29(5):565-580. doi: 10.1080/10503307.2017.1422216. Epub 2018 Jan 16.

    PubMed 29336228

  • Zilcha-Mano S, Keefe JR, Chui H, Rubin A, Barrett MS, Barber JP. Reducing Dropout in Treatment for Depression: Translating Dropout Predictors Into Individualized Treatment Recommendations. J Clin Psychiatry. 2016 Dec;77(12):e1584-e1590. doi: 10.4088/JCP.15m10081.

    PubMed 28086005

  • Zilcha-Mano S, Dinger U, McCarthy KS, Barrett MS, Barber JP. Changes in well-being and quality of life in a randomized trial comparing dynamic psychotherapy and pharmacotherapy for major depressive disorder. J Affect Disord. 2014 Jan;152-154:538-42. doi: 10.1016/j.jad.2013.10.015. Epub 2013 Oct 16.

    PubMed 24176534

  • Barber JP, Barrett MS, Gallop R, Rynn MA, Rickels K. Short-term dynamic psychotherapy versus pharmacotherapy for major depressive disorder: a randomized, placebo-controlled trial. J Clin Psychiatry. 2012 Jan;73(1):66-73. doi: 10.4088/JCP.11m06831. Epub 2011 Nov 29.

    PubMed 22152401

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Supportive Expressive Therapy, Sertraline and Venlafaxine in people with Depression, run by University of Pennsylvania at 1 site 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 1 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 2 Jun 2017. 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 2 Jun 2017). 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 Rating Scale for Depression-17 Item (time frame: symptoms assessed during past 7 days, measure taken at baseline, week 8 and week 16). 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 NCT00043550, 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 2 Jun 2017.

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