DepressionPhase 1/2NCT00051207
Therapy for Depression With Co-occurring Panic or Anxiety Symptoms
A Phase 1/2 study testing Interpersonal Psychotherapy (IPT) and IPT for Depression with Co-occurring Panic and Anxiety Symptoms (IPT-PS) in people with Depression and Anxiety Disorders, run by University of Pittsburgh at 1 site in United States.
Trial summary
This 6-month study, with a 3-month follow up period, will compare the effectiveness of new and traditional psychotherapies for depression with panic or anxiety symptoms. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression, Anxiety Disorders, Panic Disorder
- What is being tested?
- Interpersonal Psychotherapy (IPT) and IPT for Depression with Co-occurring Panic and Anxiety Symptoms (IPT-PS)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Aug 2005
- Phase
- Phase 1/2
- 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
- DSM-IV diagnosis of major depression with co-existing panic or anxiety symptoms.
Who cannot join
- History of manic episode(s). Patients who have had hypomanic episodes in the past will be accepted into the study, provided they meet other admission criteria and are not presenting in a current hypomanic or mixed episode.
- History of schizophrenia or schizoaffective disorder.
- Organic affective syndrome.
- Unspecified functional psychosis.
- Anorexia nervosa or bulimia nervosa. Patients meeting criteria for an eating disorder not otherwise specified will not be excluded.
- Chronic drug or alcohol abuse/dependence within the past 2 years. Patients with abuse related to episodes will not be excluded.
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- DSM-IV criteria for borderline or antisocial personality disorder. Patients who meet criteria for other Axis II disorders will not be excluded.
- Inpatient treatment due to suicide risk or psychotic symptoms.
- Index episode secondary to the effect of medically prescribed drugs.
- Significant or untreated medical illness, including cardiovascular disorder, renal or liver disease, epilepsy, untreated hypertension, or unstabilized endocrine disease.
- Medical illness that would interfere with the best treatment strategy for the potential participant.
- Current treatment with an antidepressant. Patients on a stable dose of anxiolytics for at least 3 months prior to study participation who are able to maintain this dosage throughout the study will not be excluded.
- Pregnant and breast-feeding women will be accepted into the study, but will not be prescribed adjunctive medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute and Clinic - Depression and Manic Depression Program
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Interpersonal Psychotherapy for Depression With Co-occurring Panic and Anxiety Symptoms (IPT-PS)
This 6-month study, with a 3-month follow up period, will compare the effectiveness of new and traditional psychotherapies for depression with panic or anxiety symptoms.
Read the detailed description
Many depressed patients also experience significant symptoms of panic or anxiety. This study will compare the effectiveness of a new therapy called interpersonal psychotherapy for depression with panic or anxiety symptoms (IPT-PS) with that of traditional interpersonal psychotherapy for depression (IPT).
Participants are randomly assigned to receive up to 24 weeks of treatment with either IPT-PS or traditional IPT. Improvements in interpersonal functioning, quality of life, and symptoms of depression and anxiety will be assessed at the end of therapy and at a 3-month follow-up.
- Conditions
- Depression, Anxiety Disorders, Panic Disorder
- Being tested
- Interpersonal Psychotherapy (IPT), IPT for Depression with Co-occurring Panic and Anxiety Symptoms (IPT-PS)
- Keywords
- Mood Disorders, Psychotherapy, Comorbidity
- Medical subject headings
- Depression, Anxiety Disorders, Panic Disorder, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal Psychotherapy (IPT)Behavioural
IPT for Depression with Co-occurring Panic and Anxiety Symptoms (IPT-PS)Behavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2003 (estimated)
- Study startNov 2002
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051207
- Sponsor's protocol ID
- R21MH061948
- Other IDs
- DSIR AT-AS
- Status last verified
- Dec 2007
- First submitted
- 7 Jan 2003
- Last updated
- 25 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interpersonal Psychotherapy for Depression With Co-occurring Panic and Anxiety Symptoms (IPT-PS)
- ClinicalTrials.gov ID
- NCT00051207
- Acronym / sponsor ID
- R21MH061948
- Conditions
- Depression, Anxiety Disorders, Panic Disorder
- Keywords
- Mood Disorders, Psychotherapy, Comorbidity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Nov 2002
- Study completion
- Aug 2005 (actual)
- First posted
- 8 Jan 2003 (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.
This 6-month study, with a 3-month follow up period, will compare the effectiveness of new and traditional psychotherapies for depression with panic or anxiety symptoms.
Detailed description
Many depressed patients also experience significant symptoms of panic or anxiety. This study will compare the effectiveness of a new therapy called interpersonal psychotherapy for depression with panic or anxiety symptoms (IPT-PS) with that of traditional interpersonal psychotherapy for depression (IPT).
Participants are randomly assigned to receive up to 24 weeks of treatment with either IPT-PS or traditional IPT. Improvements in interpersonal functioning, quality of life, and symptoms of depression and anxiety will be assessed at the end of therapy and at a 3-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- DSM-IV diagnosis of major depression with co-existing panic or anxiety symptoms.
Key exclusion criteria (13 listed)
- History of manic episode(s). Patients who have had hypomanic episodes in the past will be accepted into the study, provided they meet other admission criteria and are not presenting in a current hypomanic or mixed episode.
- History of schizophrenia or schizoaffective disorder.
- Organic affective syndrome.
- Unspecified functional psychosis.
- Anorexia nervosa or bulimia nervosa. Patients meeting criteria for an eating disorder not otherwise specified will not be excluded.
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 |
|---|---|---|
| Interpersonal Psychotherapy (IPT) | Behavioural | – |
| IPT for Depression with Co-occurring Panic and Anxiety Symptoms (IPT-PS) | Behavioural | – |
Primary outcome
Not reported in the source record.
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 25 Jun 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Interpersonal Psychotherapy (IPT) and IPT for Depression with Co-occurring Panic and Anxiety Symptoms (IPT-PS) in people with Depression and Anxiety Disorders, 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 13 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 25 Jun 2013. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 25 Jun 2013.