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Bipolar DepressionPhase 2NCT00893841

Bipolar Study of Seroquel XR With Pramipexole Dihydrochloride

A Phase 2 study testing quetiapine (Seroquel) XR and pramipexole dihydrochloride in people with Bipolar Depression, run by Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc. at 9 sites in 2 countries.

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 study is designed to assess the use of pramipexole dihydrochloride and quetiapine (Seroquel) XR as combination therapy for bipolar depression. The proposed benefit of the combination therapy investigated in this study is improved treatment of bipolar depression. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bipolar Depression
What is being tested?
quetiapine (Seroquel) XR and pramipexole dihydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
9 sitesin 2 countries
Study dates
Feb 2009to Jan 2013
Phase
Phase 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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • You must be between 18 years and 65 years of age.
  • You must have been diagnosed with bipolar depression.
  • You must (for women who are able to become pregnant) have a negative urine human chorionic gonadotropin (HCG) pregnancy test at enrolment and be using a reliable form of birth control for the entire duration of the study. The study staff will inform about what is considered an acceptable method of birth control.
  • You must provide consent.
  • You must be able to understand and comply with the requirements of the study

Who cannot join

  • You are pregnant or lactating (breast-feeding),
  • Your symptoms are due to the direct physiological effects of a substance (e.g. drug of abuse, medication, or other treatment) or a general medical condition,
  • You have a primary psychotic disorder (e.g., schizophrenia),
  • You have a personality disorder diagnosis which in the study doctor's opinion is the focus of clinical concern.
  • You have a history or presence of any psychotic illness, including major depression with psychotic features.
  • In the opinion of the study doctor, you pose an imminent risk of suicide or a danger to yourself or others,
Show all 16Show fewer
  • You have known allergies to quetiapine or to components of the medication capsule,
  • You use any "prohibited" medications. You must inform the study coordinator or study doctor of all the medications that you are taking, and he/she will tell you if any of those medications exclude you from the study.
  • You have a substance dependence (drug or alcohol dependence) which in the study doctor's opinion is the focus of clinical concern,
  • You have a medical condition that would affect absorption, distribution, metabolism, or excretion of the medication,
  • You have an unstable or inadequately treated medical illness (e.g. unstable diabetes, angina pectoris, hypertension) as judged by the study doctor,
  • You have diabetes mellitus (DM) which, in the opinion of the study doctor, would exclude you from the study,
  • You have an absolute neutrophil count (ANC) of ≤1.5 x 109 per liter
  • You are involved in the planning and conduct of the study ,
  • You were previously enrolled or randomized in this present study,
  • You participated in another drug trial within 4 weeks prior enrolment into this study

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

Canada7 sites

  • Dr. P. Chokka

    Edmonton, Alberta, T6L 6W6

  • Regional Mental Health Care - London

    London, Ontario, N6A 4H1

  • Hôpital Louis-H.Lafontaine

    Montreal, Quebec, H1N 3M5

  • Penticton Regional

    Penticton, British Columbia, V2A 4M4

  • Clinique Marie Fitzbach

    Québec, Quebec, G1R 2W8

  • AK Munshi Medical Inc.

    Sydney, Nova Scotia, B1S 2E8

  • Copeman Neuroscience Centre

    Vancouver, British Columbia, V6Z 2L4

Other trials in Canada

United States2 sites

  • Eastside Therapeutic Resource

    Kirkland, Washington, 98033

  • Affiliated Research Institute

    San Diego, California, 92108

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo Controlled Exploratory Study of Augmentation of Seroquel XR With Pramipexole Dihydrochloride for Bipolar Depression

This study is designed to assess the use of pramipexole dihydrochloride and quetiapine (Seroquel) XR as combination therapy for bipolar depression. The proposed benefit of the combination therapy investigated in this study is improved treatment of bipolar depression.

Read the detailed description

Quetiapine is a first-line option in Canadian guidelines for the treatment of bipolar depression; however, there is room for improvement as the remission rate is approximately 50% and the response rate is approximately 60%. Pramipexole, which is currently used to treat Parkinson's disease and restless legs syndrome, is reported to have antidepressant effects in patients with unipolar or bipolar depression. There are no other clinical studies to evaluate the efficacy of pramipexole combined with an atypical antipsychotic, such as quetiapine XR, in the treatment of bipolar depression.

This study is a multicentre, randomized, double-blind and placebo-controlled exploratory study in which patients will receive one of three treatment arms for a treatment period of 16 weeks: quetiapine XR plus placebo, quetiapine XR plus 0.25mg pramipexole, or quetiapine XR plus 0.50mg pramipexole.

Being tested
quetiapine (Seroquel) XR, placebo, pramipexole dihydrochloride
Keywords
bipolar, bipolar depression, bipolar disorder, depression, quetiapine, pramipexole, Seroquel XR, Mirapex
Medical subject headings
Bipolar Disorder, Depression

What participants receive

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

  • quetiapine (Seroquel) XRDrug

    Also called Seroquel XR

    tablets and caplets, take with liquid before bedtime

  • quetiapine (Seroquel) XRDrug

    Also called Seroquel XR

    tablets, take with liquid before bedtime

  • placeboDrug

    placebo

  • pramipexole dihydrochlorideDrug

    Also called mirapex

    tablets and caplets, take with liquid before bedtime

Study groups in NCT00893841
Study groupRoleWhat they receive
1Placebo comparatorQuetiapine XR 300mg + Placebo
Receives: Drug: quetiapine (Seroquel) XR; Drug: placebo
2ExperimentalQuetiapine XR 300mg + Pramipexole 0.25mg
Receives: Drug: quetiapine (Seroquel) XR; Drug: pramipexole dihydrochloride
3ExperimentalQuetiapine XR 300mg + Pramipexole 0.50mg
Receives: Drug: quetiapine (Seroquel) XR; Drug: pramipexole dihydrochloride

What is being measured

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

  1. Montgomery-Asberg Depression Rating Scale (MADRS) total score

    Measured: Week 0 to Week 16

Secondary outcomes (14)

  1. The mean change in MADRS total score

    Measured: Week 0 to Week 8

  2. Proportion of subjects achieving remission (MADRS score of less than or equal to 10)

    Measured: Week 16

  3. Proportion of subjects achieving response (reduction of at least 50% in MADRS total score)

    Measured: Week 0 to Week 16

  4. Mean change in HAM-D 21 total score

    Measured: Week 0 to Week 16

  5. Proportion of subjects achieving remission (HAM-D 21 total score of less than or equal to 7)

    Measured: Week 16

  6. Proportion of subjects achieving treatment response (reduction of at least 50% in HAM-D 21 total score)

    Measured: Week 0 to Week 16

  7. Mean change in Vancouver Semi-Structured Interview for Depression (V-SID) total score

    Measured: Week 0 to Week 16

  8. Proportion of subjects withdrawing from study due to inadequate control of depressive symptoms

    Measured: Week 0 - 16

  9. Change in neurocognitive function, assessed by CNS Vital Signs

    Measured: Week 0 to Week 16

  10. Change in neuroimmune biological markers

    Measured: Week 0 to Week 16

  11. Adverse events and patient withdrawal due to adverse events

    Measured: Week 0 - Week 16

  12. Treatment emergent mania

    Measured: Week 0 - Week 16

  13. Treatment-emergent extra-pyramidal symptoms

    Measured: Week 0 - Week 16

  14. Metabolic effects

    Measured: Week 0 - 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 posted6 May 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionJan 2013
  4. Study completionJan 2013

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00893841
Sponsor's protocol ID
D1443C00032
Status last verified
Feb 2013
First submitted
4 May 2009
Last updated
4 Feb 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing quetiapine (Seroquel) XR and pramipexole dihydrochloride in people with Bipolar Depression, run by Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc. at 9 sites in 2 countries.

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 5 inclusion and 16 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 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Canada, 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 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.

What does the primary outcome measure?

Montgomery-Asberg Depression Rating Scale (MADRS) total score (time frame: Week 0 to 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 NCT00893841.

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 4 Feb 2013.

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