CClinicalTrials.gg
Sign In
CompletedNCT00893841Updated Feb 4, 2013

Bipolar Study of Seroquel XR With Pramipexole Dihydrochloride

A Phase 2 interventional study of quetiapine (Seroquel) XR and quetiapine (Seroquel) XR in Bipolar Depression, sponsored by Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.. Completed at 9 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-02-04.

Sponsored by Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Bipolar Depression

Keywords

  • bipolar
  • bipolar depression
  • bipolar disorder
  • depression
  • quetiapine
  • pramipexole
  • Seroquel XR
  • Mirapex
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 96 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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,
  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
96 participants (actual)

Study arms

  • Placebo comparator
    1

    Quetiapine XR 300mg + Placebo

    Drug: quetiapine (Seroquel) XR · Drug: placebo

  • Experimental
    2

    Quetiapine XR 300mg + Pramipexole 0.25mg

    Drug: quetiapine (Seroquel) XR · Drug: pramipexole dihydrochloride

  • Experimental
    3

    Quetiapine XR 300mg + Pramipexole 0.50mg

    Drug: quetiapine (Seroquel) XR · Drug: pramipexole dihydrochloride

Interventions

  • Drugquetiapine (Seroquel) XR

    tablets and caplets, take with liquid before bedtime

    Also known as: Seroquel XR

  • Drugquetiapine (Seroquel) XR

    tablets, take with liquid before bedtime

    Also known as: Seroquel XR

  • Drugplacebo

    placebo

  • Drugpramipexole dihydrochloride

    tablets and caplets, take with liquid before bedtime

    Also known as: mirapex

06

What researchers measure

Primary outcomes

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

    Time frame: Week 0 to Week 16

Secondary outcomes

  1. The mean change in MADRS total score

    Time frame: Week 0 to Week 8

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

    Time frame: Week 16

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

    Time frame: Week 0 to Week 16

  4. Mean change in HAM-D 21 total score

    Time frame: Week 0 to Week 16

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

    Time frame: Week 16

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

    Time frame: Week 0 to Week 16

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

    Time frame: Week 0 to Week 16

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

    Time frame: Week 0 - 16

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

    Time frame: Week 0 to Week 16

  10. Change in neuroimmune biological markers

    Time frame: Week 0 to Week 16

  11. Adverse events and patient withdrawal due to adverse events

    Time frame: Week 0 - Week 16

  12. Treatment emergent mania

    Time frame: Week 0 - Week 16

  13. Treatment-emergent extra-pyramidal symptoms

    Time frame: Week 0 - Week 16

  14. Metabolic effects

    Time frame: Week 0 - Week 16

07

Study locations

9 sites
  • Affiliated Research Institute
    San Diego, California 92108, United States
  • Eastside Therapeutic Resource
    Kirkland, Washington 98033, United States
  • Dr. P. Chokka
    Edmonton, Alberta T6L 6W6, Canada
  • Penticton Regional
    Penticton, British Columbia V2A 4M4, Canada
  • Copeman Neuroscience Centre
    Vancouver, British Columbia V6Z 2L4, Canada
  • AK Munshi Medical Inc.
    Sydney, Nova Scotia B1S 2E8, Canada
  • Regional Mental Health Care - London
    London, Ontario N6A 4H1, Canada
  • Hôpital Louis-H.Lafontaine
    Montreal, Quebec H1N 3M5, Canada
  • Clinique Marie Fitzbach
    Quebec, G1R 2W8, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00893841
Lead sponsor
Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.
Collaborators
AstraZeneca
Responsible party
Sponsor
First posted
May 6, 2009
Start date
Feb 2009
Primary completion
Jan 2013
Completion
Jan 2013
Last update
Feb 4, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Depression→

Other studies from this sponsor

Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc.

Start the discussion