AzTrials
AzTrials

DepressionPhase 1NCT00745017

Stress Generation and Recurrent Depression: The Role of Differential Treatment Response

A Phase 1 study testing Cognitive Behavioral Therapy, Interpersonal Therapy and Antidepressant medication in people with Depression and Major Depressive Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.

Completed

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

Official record
Search all trials

Trial summary

Depression affects over one million people in Canada, resulting in $14.4 billion per year in costs to Canadian society. In order to prevent this often lifelong disorder, it is critically important to identify risk factors for the recurrence of depression. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Depression, Major Depressive Disorder
What is being tested?
Cognitive Behavioral Therapy, Interpersonal Therapy and Antidepressant medication
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteCanada
Study dates
Jul 2001to Jul 2006
Phase
Phase 1
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Meet the criteria for DSM-IV diagnosis of non-psychotic, major depression based on the Structured Interview for DSM-IV, Axis I disorders
  • Score > 16 the 17-item Hamilton Rating Scale for Depression
  • Ages between 18 and 60
  • Are medication-free (i.e., of antidepressants) for a minimum of two weeks prior to treatment are eligible for entry into treatment protocols
  • Minimum eight grade education and fluency in reading English
  • Ability to give informed consent and complete assessment instruments unassisted

Who cannot join

  • a SCID-I diagnosis of:
  • Bipolar Disorder (past or present),
  • Schizoaffective Disorder,
  • Schizophrenia,
  • Substance Abuse Disorder (current or within the past 6 months),
  • Borderline or Antisocial Personality Disorder,
Show all 9Show fewer
  • Organic Brain Syndrome
  • Electroconvulsive Therapy (ECT) within the past 6 months
  • Concurrent active medical illness

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Centre for Addiction and Mental Health

    Toronto, Ontario, M5T 1R8

Other trials in Canada

About this study

Depression affects over one million people in Canada, resulting in $14.4 billion per year in costs to Canadian society. In order to prevent this often lifelong disorder, it is critically important to identify risk factors for the recurrence of depression. A crucial force in maintaining depression is the generation of stressful life events. That is, individuals who have a history of depression are likely to generate the very events that precipitate future depressive episodes (e.g., relationship break-up, fired from job, conflicts with the law) due to negative personality characteristics and disrupted social support networks resulting from previous episodes. This project is the first to test a model that examines the role of negative personality, low social support, and childhood abuse and neglect as risk factors for the generation of stressful life events that predict future depression. We will test this model in a group of patients meeting formal criteria for depression who will be treated and then followed up for 12 months or until depression recurrence. With this long-term design we will be in a unique position to understand how depression is maintained over time, thus suggesting important treatment strategies to prevent depression recurrence.

Read the detailed description

The National Institute of Mental Health (NIMH) Treatment of Depression Collaborative Research Programme (TDCRP) (Elkin et al., 1989; Sotsky et al., 1991) compared three forms of treatment for depression -- imipramine plus clinical management (IMI-CM), cognitive behaviour therapy alone (CBT), interpersonal therapy alone (IPT) -- against a placebo control plus clinical management (PLA-CM) condition. These three treatments were found equally effective in the treatment of the index episode of depression when compared to the placebo control (Elkin et al., 1989). The results from the TDCRP study also indicated that patient characteristics, irrespective of treatment modality, were predictive of treatment effects. Six patient dimensions -- social dysfunction, cognitive dysfunction, expectation for improvement, endogenous features, double depression and duration of current episode -- were all found to be significant predictors of outcome (Sotsky et al., 1991). Patient characteristics were also found to be associated with differential outcome depending on treatment modality. Elevated social dysfunction, for example, interfered with successful outcome in IPT, whereas cognitive dysfunction hindered successful outcome with CBT. Cognitive dysfunction also predicted poor treatment response in the IMI-CM condition. Cognitive vulnerability would be expected to mediate response to treatment in CBT, as the presumed mechanism of change is dysfunctional depressogenic cognitions (e.g., Beck et al., 1979; Whisman, 1993). The finding that cognitive vulnerability was also implicated in treatment response to a pharmacological intervention is without theoretical explanation or specific causal agency.

The purpose of the proposed research is to further examine the relationship between treatment outcome and patient characteristics associated depression. In particular, the relationship between treatment outcome and two personality/cognitive characteristics implicated as vulnerability factors for depression - self-criticism and dependency - will be explored.

The first aim of the proposed investigation is to examine the relationship between change in self-criticism and dependency and the relationship of this change to treatment response and reduction in severity of depression. Mode-specific outcome measures will be administered to outpatients with major depression randomly assigned and treated with CBT, IPT or PHT.

The second aim of this study is to examine the issue of whether successful targeting of either cognitive dysfunction in CBT or interpersonal functioning in IPT will result in a reduced risk for relapse and/or recurrence of a major depressive episode.

We believe that the dependent type, who centres their definition of self entirely around issues of affiliation with others, would be more likely to show changes related to such themes in a therapeutic intervention specifically designed to address interpersonal problems. In contrast, the self-critic who defines self primarily around issues related to achievement and engages in excessively harsh and unrealistic self-appraisal would respond best to an intervention that targeted these punitive cognitions.

HYPOTHESES/RESEARCH QUESTIONS

Prediction of Treatment Outcome (Objective 1):

Two sets of hypotheses are proposed. In all analyses the DEQ will be used to assess self-criticism and dependency. The first set of hypotheses involves mode specific treatment outcomes and the second set of hypotheses address differences in the mechanisms of change across the treatments.

The first set of hypotheses are: (a) all treatments will be equally effective in the treatment of the index episode, (b) baseline self-criticism and dependency scores will predict outcome in all treatments, with higher self-criticism and dependency scores related to poor outcome, (c) CBT will demonstrate greater specificity for targeting self-criticism than will either PHT or IPT, (d) IPT will demonstrate greater specificity for treating interpersonal functioning than will either PHT or CBT, (e) PHT will demonstrate greater specificity for treating endogenous symptoms than will either CBT or IPT.

The second set of hypotheses are: (a) change in self-criticism scores and dysfunctional cognitions will mediate a positive treatment response in CBT but not in IPT or PHT, (b) change in dependency scores and interpersonal deficits will mediate positive treatment response in IPT but not in CBT or PHT, (c) change in endogeneity will mediate positive treatment response in PHT but not in CBT or IPT.

Prediction of Relapse and Recurrence (Objective 2):

It is hypothesized that: (a) CBT and IPT will produce a lower rate of relapse and recurrence than PHT because of the greater reduction in stable dysfunctional cognitions related to either self-critical and/or interpersonal vulnerabilities; (b) in cases where interpersonal vulnerabilities are predominant, IPT will produce lower rates of relapse and recurrence than either CBT and PHT, in cases where self-critical vulnerabilities are predominant, CBT will produce lower rates of relapse and recurrence than either IPT or PHT.

Being tested
Cognitive Behavioral Therapy, Interpersonal Therapy, Antidepressant medication
Keywords
recurrent depression, major depressive disorder, interpersonal therapy, cognitive behavioral therapy, antidepressant therapies, outome predictors, personality dimensions
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.

  • Cognitive Behavioral TherapyBehavioural

    All patients randomized to this condition will receive 16 consecutive weeks of manualized cognitive-behaviour therapy provided by either M.S.W or Ph.D. psychotherapists trained and certified in CBT. Treatment will be conducted according to the manualized CBT treatment for depression outlined by Beck and colleagues (Beck et al., 1979), and consistent with the protocol administered in the NIMH study.

  • Interpersonal TherapyBehavioural

    All patients randomized to this condition will receive 16 consecutive weeks of manualized interpersonal psychotherapy conducted by M.S.W., Ph.D., or M.Ed. psychotherapists trained and certified in IPT.

  • Antidepressant medicationDrug

    Patients patients randomized to this condition will be treated for 16 weeks with different classes of anti-depressant medications, using standardized protocols. Patients will receive 16 weeks of treatment with either a SSRI (sertraline or paroxetine) or a SNRI (venlafaxine). The dose range is as follows: sertraline 50-200 mg/day, paroxetine 20-40 mg/day, venlafaxine 75-375 mg/day. Patients unable to continue with the prescribed medication due to side effects and/or lack of response will be prescribed an alternate medication during the first two weeks of the protocol.

Study groups in NCT00745017
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Behavioral: Cognitive Behavioral Therapy
2ExperimentalNot described
Receives: Behavioral: Interpersonal Therapy
3ExperimentalNot described
Receives: Drug: Antidepressant medication

What is being measured

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

  1. Hamilton Rating Scale for Depression

    Measured: intermittent

Timeline

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

  1. First posted1 Sep 2008 (estimated)
  2. Study startJul 2001
  3. Primary completionJul 2006

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00745017
Sponsor's protocol ID
091/2003
Status last verified
Aug 2008
First submitted
28 Aug 2008
Last updated
1 Sep 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cognitive Behavioral Therapy, Interpersonal Therapy and Antidepressant medication in people with Depression and Major Depressive Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.

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 9 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 1 Sep 2008. 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 Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 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?

Hamilton Rating Scale for Depression (time frame: intermittent). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 1 Sep 2008.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in