Major DepressionPhase 4NCT00222820
Depression: The Search for Treatment-Relevant Phenotypes-Pilot Study
A Phase 4 study testing escitalopram and Interpersonal Psychotherapy in people with Major Depression, run by University of Pittsburgh at 1 site in United States.
Trial summary
We are doing this pilot study to learn more about four aspects of treating depression: 1. The features of a depressed person's mood and anxiety and how these features affect a person's capacity to get better and stay better. 2. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression
- What is being tested?
- escitalopram and Interpersonal Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Sep 2004
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Men and women 2 Age 18-65 3. Currently experiencing an episode of major depression 4. Not currently receiving effective treatment 5. Females of childbearing potential: practicing an acceptable form of birth control 6. Subjects with suicidal ideation are eligible as long as outpatient treatment is deemed safe 7. Willingness and ability to give informed consent.
Who cannot join
- History of manic or hypomanic episodes;
- History of schizophrenia or schizoaffective disorder;
- Current primary diagnosis of anorexia nervosa or bulimia nervosa;
- Current psychosis;
- Drug and/or alcohol dependence or abuse within the past three months (episodic abuse related to mood episodes will not exclude a subject);
- Antisocial personality disorder (other Axis II disorders will not be exclusionary);
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- Organic affective syndrome;
- Renal or liver disease;
- Epilepsy;
- Cardiovascular disease;
- Uncontrolled illnesses, including untreated hypertension or unstable endocrine diseases.
- Women who are or are plan to become pregnant during the course of this study
- Subjects who require inpatient treatment because of suicidal risk or psychosis
- Subjects with a well-documented history of an inability to tolerate one of the study treatments or are currently receiving treatment with an effective antidepressant therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychaitric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Depression: The Search for Treatment-Relevant Phenotypes
We are doing this pilot study to learn more about four aspects of treating depression:
- The features of a depressed person's mood and anxiety and how these features affect a person's capacity to get better and stay better.
- If depressed people with certain features of mood and anxiety respond better to therapy, medication or a combination of therapy and medication.
- Whether or not a person's personality traits affect how they respond to treatment.
- The gene involved in processing antidepressant medication
Read the detailed description
This pilot study is an experimental investigation designed so that consenting subjects are randomly assigned to pharmacotherapeutic or psychotherapeutic interventions for depression.
For the initial phase of treatment, subjects will be randomly assigned to treatment with an SSRI, (escitalopram oxalate or citalopram hydrobromide), or with interpersonal psychotherapy (IPT). Escitalopram will be prescribed for all patients randomized to the medication arm of the study, unless the study psychiatrist determines that citalopram is more clinically appropriate. Escitalopram and citalopram are FDA-Approved SSRI antidepressants indicated for the treatment of depression. In order to optimize outcomes and emulate usual clinical practice, subjects who do not meet response criteria (defined as a 50% reduction in baseline Hamilton Rating Scale for Depression [HRS-D]) or meet stabilization criteria (defined as a mean HRS-D < 7 for 3 weeks) at acute phase Visit 7 or Visit 13 of treatment will have the other treatment added. Subjects who meet stabilization criteria (mean HRS-D < 7 for 3 weeks) at any time between acute phase Visit 13 and 21 will enter the 6-month continuation phase and continue with the treatment that led to their stabilization. Subjects who have not met stabilization criteria by acute phase Visit 21 will remain in active treatment and be offered alternative pharmacotherapy. Subjects who have not responded by acute phase Visit 32 will be discontinued from the protocol and referred for alternative treatment and care.
- Conditions
- Major Depression
- Being tested
- escitalopram, Interpersonal Psychotherapy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
escitalopramDrug
Interpersonal PsychotherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression
Secondary outcomes (1)
Inventory of Depressive Symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startApr 2002
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Mental Health Intervention Research Center (MHIRC)
- Investigators
- Ellen Frank, Ph.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222820
- Sponsor's protocol ID
- 011015
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 22 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression: The Search for Treatment-Relevant Phenotypes
- ClinicalTrials.gov ID
- NCT00222820
- Acronym / sponsor ID
- 011015
- Conditions
- Major Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Mental Health Intervention Research Center (MHIRC)
- Study start
- Apr 2002
- Study completion
- Sep 2004
- First posted
- 22 Sep 2005 (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.
We are doing this pilot study to learn more about four aspects of treating depression:
- The features of a depressed person's mood and anxiety and how these features affect a person's capacity to get better and stay better.
- If depressed people with certain features of mood and anxiety respond better to therapy, medication or a combination of therapy and medication.
- Whether or not a person's personality traits affect how they respond to treatment.
- The gene involved in processing antidepressant medication
Detailed description
This pilot study is an experimental investigation designed so that consenting subjects are randomly assigned to pharmacotherapeutic or psychotherapeutic interventions for depression.
For the initial phase of treatment, subjects will be randomly assigned to treatment with an SSRI, (escitalopram oxalate or citalopram hydrobromide), or with interpersonal psychotherapy (IPT). Escitalopram will be prescribed for all patients randomized to the medication arm of the study, unless the study psychiatrist determines that citalopram is more clinically appropriate. Escitalopram and citalopram are FDA-Approved SSRI antidepressants indicated for the treatment of depression. In order to optimize outcomes and emulate usual clinical practice, subjects who do not meet response criteria (defined as a 50% reduction in baseline Hamilton Rating Scale for Depression [HRS-D]) or meet stabilization criteria (defined as a mean HRS-D < 7 for 3 weeks) at acute phase Visit 7 or Visit 13 of treatment will have the other treatment added. Subjects who meet stabilization criteria (mean HRS-D < 7 for 3 weeks) at any time between acute phase Visit 13 and 21 will enter the 6-month continuation phase and continue with the treatment that led to their stabilization. Subjects who have not met stabilization criteria by acute phase Visit 21 will remain in active treatment and be offered alternative pharmacotherapy. Subjects who have not responded by acute phase Visit 32 will be discontinued from the protocol and referred for alternative treatment and care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Men and women 2 Age 18-65 3. Currently experiencing an episode of major depression 4. Not currently receiving effective treatment 5. Females of childbearing potential: practicing an acceptable form of birth control 6. Subjects with suicidal ideation are eligible as long as outpatient treatment is deemed safe 7. Willingness and ability to give informed consent.
Key exclusion criteria (14 listed)
- History of manic or hypomanic episodes;
- History of schizophrenia or schizoaffective disorder;
- Current primary diagnosis of anorexia nervosa or bulimia nervosa;
- Current psychosis;
- Drug and/or alcohol dependence or abuse within the past three months (episodic abuse related to mood episodes will not exclude a subject);
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 |
|---|---|---|
| escitalopram | Drug | – |
| Interpersonal Psychotherapy | Behavioural | – |
Primary outcome
Hamilton Rating Scale for Depression
1 secondary outcome
Inventory of Depressive Symptoms
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 22 Sep 2005.
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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.
Ellen Frank, Ph.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing escitalopram and Interpersonal Psychotherapy in people with Major Depression, run by University of Pittsburgh 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 14 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 22 Sep 2005. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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. 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 22 Sep 2005.